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NCT Number: NCT06736496

Comparative Study of Opioid-Free Anesthesia Versus Opioid Anesthesia in Patients Undergoing Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is an effective surgical approach for the treatment of gallbladder disorders such as cholecystitis, gallbladder stones or gallbladder polyps. Although the surgical technique for the treatment of cholecystitis with laparoscope shows some gains compared to open surgery, postoperative complications such as abdominal incision pain, nausea and vomiting, or other complications are still challenging issues.

Thus, there is a need to study and evaluate new non-opioid pain medications after laparoscopic cholecystectomy as part of an opioid reduction strategy.the aim of the study is To compare the effectiveness and safety of opioid-free anesthesia versus opioid-based anesthesia in patients undergoing laparoscopic cholecystectomy, focusing on pain management, postoperative recovery, and incidence of adverse effects.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Anesthesia requires a full spectrum of drugs, from which an anesthetic plan can be applied to achieve the desired level of sedation, analgesia, amnesia, muscle relaxation, and reflex abolition.

Opioid administration as a bolus dose or continuous infusion is commonly used by anesthesiologists in major and day care surgeries. Using of opioids during anesthesia is associated with various opioid-related adverse effects such as respiratory depression, opioid-induced hyperalgesia, nausea and vomiting, urinary retention, paralytic ileus, and the risk of cognitive and sleep dysfunction , This negative side effect profile of opioids may cause delayed recovery and discharge of patients from the post-anesthesia care unit as well as unanticipated hospital readmissions.

The emergence of opioid-free anesthesia was prompted by the adverse effects of opioids and the ongoing opioid epidemic.

Opioid-free anesthesia is a multimodal anesthetic and analgesic without the use of opioid drugs and can play a crucial role in enhanced recovery after surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • o Adults aged 18-65 years.
  • Scheduled for elective laparoscopic cholecystectomy.
  • ASA Physical Status I-III.
  • Provided informed consent.

Exclusion criteria

  • patients with a history of alcohol or drug abuse.
  • Chronic opioid use or dependence.
  • basal heart rate (HR) ≤ 50 beats/min.
  • Allergies to study medications.
  • Severe renal or hepatic impairment.
  • Pregnancy or lactation.

Treatment and study plan

Nalbuphine

Drug

patients will receive : nalbuphine administered at a dose of 0.2 mg / kg IV bolus dose before induction and intermittent doses of 0.5 mg/kg if MAP and HR greater than 20% of the base line value.

Dexmedetomidine

Drug

patients will receive : Dexmedetomidine infusion at rate of 0.5mcg/kg/h initiated 10 min before induction and ketamine iv bolus dose of 0.35 mg/kg and Lidocaine iv bolus dose of 1mg/kg administrated before skin incision.

Primary outcomes

  1. amount of opioid consumption

    Time frame: 24 hours

    Total opioid consumption in the postoperative period.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Ahmed Mokhtar Mohamed, resident doctor

CONTACT

[email protected]

+201070099391

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2024
Registry last updated
Dec 16, 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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