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NCT Number: NCT06042816

Analgesic Efficacy of Free-opioid Anesthesia for Colorectal Surgery

Objectives: To compare free-opioid anesthesia (the combination of epidural anesthesia, intravenous lidocaine, ketamine, propofol, and sevoflurane) and opioid anesthesia (fentanyl, propofol and sevoflurane) regarding intraoperative analgesic efficacy in colectomies and rectal resections at Viet Tiep Friendship Hospital.

Methods: A prospective, randomized controlled clinical trial was performed on 98 patients who were anesthetized for colorectal surgery from December 2019 to November 2021. Patients were randomized into 2 groups: Group OA - Opioid anesthesia (n = 49): Intraoperative pain control by fentanyl; FOA group - Free-opioid anesthesia (n = 49): Intraoperative pain control by continuous infusion of lidocaine, bolus doses of ketamine combined with epidural levobupivacaine.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Viet-Tiep Friendship Hospital

Haiphong, Le Chan, 184570, Vietnam

About this study

After being placed an epidural catheter and given a bolus dose of dexamethasone 0.1 mg/kg, patients was endotracheal anesthetized with propofol 1% 2-2.5 mg/kg, rocuronium 0.6 mg/kg. Intubation was implemented when TOF (Train Of Four)=0 and RE (Response Entropy), SE (State Entropy) ≤ 60. Patients in OA group received a bolus dose of fentanyl 2 µg/kg before induction of anesthesia while those in FOA group received bolus doses of lidocaine 1 mg/kg and ketamine 0.5 mg/kg. In FOA group, lidocaine 10% was sprayed on the patients glottis to facilitate intubation.

For anesthesia maintenance, in group OA, a bolus dose of fentanyl 3 µg/kg was given 5 minutes before skin incision, and then a continuous infusion of fentanyl 2 µg/kg/h was maintained for intraoperative pain management; fentanyl 0.5 μg/kg was bolused when SPI (Surgical Pleth Index) > 50, 40 < SE < 60, TOF = 0 and the patient was hemodynamically stable. Propofol and fentanyl were discontinued at the start of skin closure. In FOA group, patients received intraoperative multimodal analgesia, in which an epidural bolus of 3 - 5 ml of levobupivacaine 0.1% was followed by a continuous infusion of 3 - 5 ml/h epidurally; in addition, intravenous infusion of lidocaine 1 mg/kg/hour and ketamine 0.25 mg/kg/h were maintained until the end of surgery. Patients were given a bolus of 3-5 ml levobupivacaine 0.1% epidurally and ketamine 0.25 mg/kg intravenously if SPI > 50, 40 < SE < 60, TOF = 0 and hemodynamics was stable.

For all patients, anesthesia was maintained by volatile anesthetics (Sevoflurane or Desflurane) to ensure 40 < SE < 60, and rocuronium 0.2 mg/kg was repeated when TOF = 2 (the last injection of neuromuscular blockade was not given when the estimated duration from the point of injection to the point of abdominal closure is shorter than 20 minutes). Mechanical ventilation was provided with a tidal volume 6-8 ml/kg in the volume-controlled mode and respiratory rate at 10-12 breath/minute, FiO2 (Fraction of inspired oxygen)=50%. Peak airway pressure was maintained within the range of 12-16 cmH2O and EtCO2 (End-tidal Carbon dioxide) was kept from 35 to 40 mmHg with a fresh gas flow of 1.2 - 2 liters/minute. At the end of surgery, reversal of neuromuscular blockade was performed with neostigmine combined with atropine, and extubation was carried out when patients met the criteria. Postoperative pain management was implemented with patient-controlled epidural levobupivacaine 0.1% for 72 hours, and pain rescue with fentanyl 0.5 μg/kg.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients agreed to participate in the study.
  • Patients aged ≥ 18 years old,
  • Those who underwent elective colectomies or rectal resections,
  • Those who were ASA (American Society of Anesthesiologists) classified as I - III,
  • Those who were indicated for general endotracheal anesthesia from December 2019 to November 2021 at Viet Tiep Friendship Hospital

Exclusion criteria

  • Patients refused to participate in the study,
  • Patients had BMI (Body Mass Index) ≥ 35;
  • Pregnant or lactating or menstruating women;
  • Those who had liver failure, renal failure, heart failure, history of chronic pain, alcohol or drug abuse, mental illnesses, allergies or contraindications to any studied medications.
  • Those who were unable to assess pain or use of patient-controlled analgesia devices (PCA).

Treatment and study plan

Free-opioid anesthesia

Procedure

Free opioid anesthesia (FOA) has been used in many countries around the world, making use of multimodal analgesia therapy which includes hypnotics, N-methyl-D-aspartate (NMDA) antagonists, local anesthetics and anti-inflammatory agents and sympathetic block in surgery. This method was demonstrated to contribute to enhanced recovery after surgery (ERAS). The use of long-acting local anesthetics also enhances postoperative pain relief. As a result, the concept of balanced anesthesia now has a change in three basic components: hypnotics, muscle relaxants and sympathomimetic inhibitors

Opioid Anesthesia

Procedure

Opioids have been used as one of three basic components of balanced anesthesia, including anesthetic drugs, pain relievers, and neuromuscular blockade agents (opioid anesthesia). Opioids not only facilitate deep anesthesia but also create the most favorable conditions for surgeries. Fentanyl is a potent opioid used to control pain, reduce the dose of sympathomimetic inhibitors and maintain hemodynamic stability. However, several common side effects of fentanyl are well known: nausea and vomiting, constipation, urinary retention, headache, pruritus, rash, histamine release, biliary spasm and respiratory depression, the most severe adverse effect

Primary outcomes

  1. analgesic efficacy of free-opioid anesthesia

    Time frame: before induction of anesthesia

    intraoperative alteration of Surgical Pleth Index (SPI). The Surgical Pleth Index (SPI) is an objective tool that can reflect nociception-antinociception balance and guide the use of intraoperative analgesics. The values of the SPI range from 0 to 100. During general anaesthesia, maintaining a value between 20 and 50 is generally recommended. When the SPI value is greater than 50 and exceeds 3-5 min, it routinely indicates that the noxious stimulation is too strong and that additional analgesic drugs are needed.

  2. analgesic efficacy of free-opioid anesthesia

    Time frame: After intubation

    intraoperative alteration of Surgical Pleth Index (SPI)

  3. analgesic efficacy of free-opioid anesthesia

    Time frame: After skin incision

    intraoperative alteration of Surgical Pleth Index (SPI)

  4. analgesic efficacy of free-opioid anesthesia

    Time frame: when the restoration of eyelids reflex emerged

    intraoperative alteration of Surgical Pleth Index (SPI)

  5. analgesic efficacy of free-opioid anesthesia

    Time frame: Intraoperatively (From the induction of anesthesia to the emergence)

    The number of times of intraoperative analgesics adjustment

  6. analgesic efficacy of free-opioid anesthesia

    Time frame: postoperatively (upto 3 days after surgery)

    the proportion of patients requiring postoperative pain rescue

Secondary outcomes

  1. Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

    Time frame: T0 (right after entering the operating theatre)

    Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.

  2. Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

    Time frame: T1 (before induction of anesthesia)

    Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.

  3. Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

    Time frame: T2 (patients lost eyelid reflex and response to verbal command)

    Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.

  4. Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

    Time frame: T3 (before intubation)

    Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.

  5. Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

    Time frame: T4 (after intubation)

    Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.

  6. Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

    Time frame: T5 (before skin incision)

    Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.

  7. Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

    Time frame: T6 (after skin incision)

    Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.

  8. Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

    Time frame: T7 (colon release)

    Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.

  9. Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

    Time frame: T8 (dissection of colorectal mesentery)

    Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.

  10. Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

    Time frame: T9 (colon resection)

    Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.

  11. Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

    Time frame: T10 (restore gastrointestinal flow)

    Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.

  12. Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

    Time frame: T11 (drainage placement)

    Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.

  13. Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

    Time frame: T12 (before skin closure)

    Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.

  14. Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

    Time frame: T13 (immediately after skin closure)

    Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.

  15. Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

    Time frame: T14 (eyelids reflex restored and patients eyes could open on command)

    Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.

  16. Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

    Time frame: T15 (before extubation)

    Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.

  17. Effects of free-opioid anesthesia on intraoperative mean arterial blood pressure

    Time frame: T16 (15 minutes after extubation)

    Non-invasive blood pressure was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The mean arterial blood pressure at each time point was compared between the two groups.

  18. Effects of free-opioid anesthesia on intraoperative heart rate

    Time frame: T0 (right after entering the operating theatre)

    Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.

  19. Effects of free-opioid anesthesia on intraoperative heart rate

    Time frame: T1 (before induction of anesthesia)

    Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.

  20. Effects of free-opioid anesthesia on intraoperative heart rate

    Time frame: T2 (patients lost eyelid reflex and response to verbal command)

    Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.

  21. Effects of free-opioid anesthesia on intraoperative heart rate

    Time frame: T3 (before intubation)

    Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.

  22. Effects of free-opioid anesthesia on intraoperative heart rate

    Time frame: T4 (after intubation)

    Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.

  23. Effects of free-opioid anesthesia on intraoperative heart rate

    Time frame: T5 (before skin incision)

    Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.

  24. Effects of free-opioid anesthesia on intraoperative heart rate

    Time frame: T6 (after skin incision)

    Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.

  25. Effects of free-opioid anesthesia on intraoperative heart rate

    Time frame: T7 (colon release)

    Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.

  26. Effects of free-opioid anesthesia on intraoperative heart rate

    Time frame: T8 (dissection of colorectal mesentery)

    Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.

  27. Effects of free-opioid anesthesia on intraoperative heart rate

    Time frame: T9 (colon resection)

    Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.

  28. Effects of free-opioid anesthesia on intraoperative heart rate

    Time frame: T10 (restore gastrointestinal flow)

    Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.

  29. Effects of free-opioid anesthesia on intraoperative heart rate

    Time frame: T11 (drainage placement)

    Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.

  30. Effects of free-opioid anesthesia on intraoperative heart rate

    Time frame: T12 (before skin closure)

    Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.

  31. Effects of free-opioid anesthesia on intraoperative heart rate

    Time frame: T13 (immediately after skin closure)

    Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.

  32. Effects of free-opioid anesthesia on intraoperative heart rate

    Time frame: T14 (eyelids reflex restored and patients eyes could open on command)

    Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.

  33. Effects of free-opioid anesthesia on intraoperative heart rate

    Time frame: T15 (before extubation)

    Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.

  34. Effects of free-opioid anesthesia on intraoperative heart rate

    Time frame: T16 (15 minutes after extubation)

    Heart rate was assessed every 5 minutes intraoperatively and recorded at some investigated time points. The heart rate at each time point was compared between the two groups.

  35. changes in the concentration of IL (Interleukin)-6

    Time frame: Before surgery

    Blood samples were collected in a heparin tube immediately before surgery (T0) and 1 hour after extubation. They were centrifuged, and then plasma was separated and stored at -70°C until being analyzed. IL-6 levels were analyzed using enzyme-linked immunosorbent assay (ELISA). Changes in IL-6 were recorded and compared between the two groups

  36. changes in the concentration of IL (Interleukin)-6

    Time frame: 1 hour after surgery

    Blood samples were collected in a heparin tube immediately before surgery (T0) and 1 hour after extubation. They were centrifuged, and then plasma was separated and stored at -70°C until being analyzed. IL-6 levels were analyzed using enzyme-linked immunosorbent assay (ELISA). Changes in IL-6 were recorded and compared between the two groups

  37. changes in the concentration of IL-10

    Time frame: Before surgery

    Blood samples were collected in a heparin tube immediately before surgery (T0) and 1 hour after extubation. They were centrifuged, and then plasma was separated and stored at -70°C until being analyzed. IL-10 levels were analyzed using enzyme-linked immunosorbent assay (ELISA). Changes in IL-10 were recorded and compared between the two groups

  38. changes in the concentration of IL-10

    Time frame: 1 hour after surgery

    Blood samples were collected in a heparin tube immediately before surgery (T0) and 1 hour after extubation. They were centrifuged, and then plasma was separated and stored at -70°C until being analyzed. IL-10 levels were analyzed using enzyme-linked immunosorbent assay (ELISA). Changes in IL-10 were recorded and compared between the two groups

  39. Adverse effects of free-opioid anesthesia

    Time frame: up to 3 days postoperatively

    the rate of patients suffering nausea and vomiting

Sponsors and collaborators

Lead sponsor

Vietnam Military Medical University

Other

Registry information

Official study title

Evaluation of the Analgesic Efficacy of Free Opioid Anesthesia for Patients Undergoing Colectomies and Rectal Resections: A Prospective, Randomized Controlled Clinical Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 21, 2023
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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