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Completed

NCT Number: NCT05750056

Dose Systemic Lidocaine Improve the Quality of Recovery After Colorectal Endoscopic Submucosal Dissection

Endoscopic submucosal dissection (ESD) is a common procedure that requires a long procedural time. Procedure Sedation is commonly provided to alleviate patients' discomfort and facilitate the implementation of procedures. We conducted a prospective study to determine the effect of intravenous infusion of lidocaine in the cognitive domain of the postoperative quality of recovery scale on day 3 after ESD.

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Key information

Conditions

Postoperative Recovery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fujian provincial hospital

Fuzhou, Fujian, China

About this study

Colorectal cancer occurred in more than 1.9 million new cases and 935,000 deaths in 2020 and ranked third in incidence and second in mortality globally. Endoscopic submucosal dissection (ESD) is the current standard for treating large colorectal polyps and has been shown to reduce colorectal cancer-related mortality. Sedation is commonly provided to alleviate patients' discomfort and facilitate the implementation of procedures.

Lidocaine is an amide local anesthetic with analgesic, anti-hyperalgesic, and anti-inflammatory properties. Its safety in appropriate amounts has been established. The current evidence gap is whether the use of systematic lidocaine affects the quality of recovery after ESD. Thus, the aim of this study is to determine the effect of intravenous infusion of lidocaine in the cognitive domain of the postoperative quality of recovery scale on day 3 after ESD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists (ASA) classification I-III;
  • Scheduled for endoscopic colorectal mucosal dissection.

Exclusion criteria

  • Patient refuses to participate;
  • BMI greater than 30;
  • Allergic or contraindication to study drugs;
  • History of chronic pain and long-term use of analgesic medication;
  • Severe arrhythmia;
  • Hepatic and renal dysfunction;
  • Any other conditions precluded study inclusion, such as cognitive impairment, pregnancy, or inability to communicate in Mandarin Chinese.

Treatment and study plan

Lidocaine

Drug

Patients received an intravenous bolus injection of lidocaine 1.5 mg/kg over 10 min before induction of anesthesia, followed by a continuous infusion of 2 mg/kg/h until the end of the procedure.

Other names: Lidocaine IV

0.9% saline

Drug

Patients received a perioperative saline infusion at the same rate and volume as the lidocaine infusion.

Other names: 0.9% sodium chloride

Propofol

Drug

An i.v. bolus injection of propofol 1 mg/kg was given to all patients. Propofol was then titrated if necessary to produce unconsciousness during the introduction of the endoscope. Afterward, the anesthesiologist determined the dose of propofol and titrated to effect.

Other names: Propofol injection

Sufentanil

Drug

Sufentail 0.1 ug/kg was administered for sedation induction.

Other names: Sufentanil injection

Primary outcomes

  1. Incidence of postoperative cognitive recovery

    Time frame: Day 3 postoperatively

    Postoperative cognitive recovery will be measured using the Postoperative Quality of Recovery Scale (PostopQRS). The PostopQRS is a multidimensional survey-based tool, which includes a domain designed to measure recovery in the cognitive domain of the PostopQRS over time during the postoperative period. The instrument is administered preoperatively to provide individual baseline measurements for each patient. Tests produce performance scores. Higher scores mean a better outcome. The recovery outcome is defined as returning to at least baseline values.

Secondary outcomes

  1. Incidence of postoperative cognitive recovery

    Time frame: 30 minutes after endoscope removal

    Postoperative cognitive recovery will be measured using the Postoperative Quality of Recovery Scale (PostopQRS). The PostopQRS is a multidimensional survey-based tool, which includes a domain designed to measure recovery in the cognitive domain of the PostopQRS over time during the postoperative period. The instrument is administered preoperatively to provide individual baseline measurements for each patient. Tests produce performance scores. Higher scores mean a better outcome. The recovery outcome is defined as returning to at least baseline values.

  2. Incidence of postoperative cognitive recovery

    Time frame: Day 1 postoperatively

    Postoperative cognitive recovery will be measured using the Postoperative Quality of Recovery Scale (PostopQRS). The PostopQRS is a multidimensional survey-based tool, which includes a domain designed to measure recovery in the cognitive domain of the PostopQRS over time during the postoperative period. The instrument is administered preoperatively to provide individual baseline measurements for each patient. Tests produce performance scores. Higher scores mean a better outcome. The recovery outcome is defined as returning to at least baseline values.

  3. Incidence of postoperative cognitive recovery

    Time frame: Day 7 postoperatively

    Postoperative cognitive recovery will be measured using the Postoperative Quality of Recovery Scale (PostopQRS). The PostopQRS is a multidimensional survey-based tool, which includes a domain designed to measure recovery in the cognitive domain of the PostopQRS over time during the postoperative period. The instrument is administered preoperatively to provide individual baseline measurements for each patient. Tests produce performance scores. Higher scores mean a better outcome. The recovery outcome is defined as returning to at least baseline values.

  4. Incidence of overall recovery

    Time frame: 30 minutes after endoscope removal

    The Postoperative Quality of Recovery Scale (PostopQRS) is a multidimensional survey-based tool, which contains physiological, emotive, nociceptive, activities of daily living, and cognitive recovery over time. Nociceptive, emotive, and activities of daily living that can be scored in a categorical fashion. In the cognitive domain, tasks receive a performance score. In the physiologic domain, values are transformed and categorized as acceptable, somewhat or far outside of the desirable boundaries, based on normative population data. Higher scores mean a better outcome, except for nociceptive domain. Overall recovery is postoperative values equaling or exceeding individual baseline values in each of the domains of the PostopQRS. The incidence of recovery is expressed as a percentage of participants recovered/group total at each time point.

  5. Incidence of overall recovery

    Time frame: Day 1 postoperatively

    The Postoperative Quality of Recovery Scale (PostopQRS) is a multidimensional survey-based tool, which contains physiological, emotive, nociceptive, activities of daily living, and cognitive recovery over time. Nociceptive, emotive, and activities of daily living that can be scored in a categorical fashion. In the cognitive domain, tasks receive a performance score. In the physiologic domain, values are transformed and categorized as acceptable, somewhat or far outside of the desirable boundaries, based on normative population data. Higher scores mean a better outcome, except for nociceptive domain. Overall recovery is postoperative values equaling or exceeding individual baseline values in each of the domains of the PostopQRS. The incidence of recovery is expressed as a percentage of participants recovered/group total at each time point.

  6. Incidence of overall recovery

    Time frame: Day 3 postoperatively

    The Postoperative Quality of Recovery Scale (PostopQRS) is a multidimensional survey-based tool, which contains physiological, emotive, nociceptive, activities of daily living, and cognitive recovery over time. Nociceptive, emotive, and activities of daily living that can be scored in a categorical fashion. In the cognitive domain, tasks receive a performance score. In the physiologic domain, values are transformed and categorized as acceptable, somewhat or far outside of the desirable boundaries, based on normative population data. Higher scores mean a better outcome, except for nociceptive domain. Overall recovery is postoperative values equaling or exceeding individual baseline values in each of the domains of the PostopQRS. The incidence of recovery is expressed as a percentage of participants recovered/group total at each time point.

  7. Incidence of overall recovery

    Time frame: Day 7 postoperatively

    The Postoperative Quality of Recovery Scale (PostopQRS) is a multidimensional survey-based tool, which contains physiological, emotive, nociceptive, activities of daily living, and cognitive recovery over time. Nociceptive, emotive, and activities of daily living that can be scored in a categorical fashion. In the cognitive domain, tasks receive a performance score. In the physiologic domain, values are transformed and categorized as acceptable, somewhat or far outside of the desirable boundaries, based on normative population data. Higher scores mean a better outcome, except for nociceptive domain. Overall recovery is postoperative values equaling or exceeding individual baseline values in each of the domains of the PostopQRS. The incidence of recovery is expressed as a percentage of participants recovered/group total at each time point.

  8. Propofol consumption

    Time frame: During the colonoscopy procedure

    Propofol consumption will be recorded during the colonoscopy procedure.

  9. Endoscopitst satisfacrion

    Time frame: At completion of colonoscopy procedure

    Endoscopitst satisfacrion will be evaluated using a five-point Likert scale (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, and 1=very dissatisfied).

  10. Patient satisfaction

    Time frame: On 1 day postoperatively

    Patient satisfaction will be evaluated using a five-point Likert scale (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, and 1=very dissatisfied).

  11. Incidence of adverse events

    Time frame: Up to 24 hours postoperatively

    Adverse events such as bradycardia, tachycardia, hypertension, hypotension, and hypoxia will be recorded during the trial.

Other outcomes

  1. Emergency time

    Time frame: Immediately after the colonoscopy completely withdrawn

    Emergency time is defined as the interval from the end of colonoscopy to the MOAA/S score equal to five.

  2. Patient willingness to recommend screening

    Time frame: Day 1 postoperatively

    Patients will be asked whether they would recommend bronchoscopy screening to a friend or a relative (Yes/No/Unsure).

  3. Patient willingness to repeat the procedure

    Time frame: Day 1 postoperatively

    Patients will be asked whether they would repeat the identical procedural process (Yes/No/Unsure)

Sponsors and collaborators

Lead sponsor

Fujian Provincial Hospital

Other

Registry information

Official study title

Effect of Intraoperative Intravenous Lidocaine on the Quality of Recovery Following Colorectal Endoscopic Submucosal Dissection

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 1, 2023
Registry last updated
May 10, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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