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

NCT06736496 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: Free vs Opioid Anesthesia
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• amount of opioid consumption

  Total opioid consumption in the postoperative period.

  24 hours

Study Arms (2)

group 1

EXPERIMENTAL

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.

Drug: Nalbuphine

group 2

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Interventions

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.

group 1

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.

group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• Blaudszun G, Lysakowski C, Elia N, Tramer MR. Effect of perioperative systemic alpha2 agonists on postoperative morphine consumption and pain intensity: systematic review and meta-analysis of randomized controlled trials. Anesthesiology. 2012 Jun;116(6):1312-22. doi: 10.1097/ALN.0b013e31825681cb.

  PMID: 22546966 BACKGROUND

• Collard V, Mistraletti G, Taqi A, Asenjo JF, Feldman LS, Fried GM, Carli F. Intraoperative esmolol infusion in the absence of opioids spares postoperative fentanyl in patients undergoing ambulatory laparoscopic cholecystectomy. Anesth Analg. 2007 Nov;105(5):1255-62, table of contents. doi: 10.1213/01.ane.0000282822.07437.02.

  PMID: 17959952 BACKGROUND

• Weibel S, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Afshari A, Kranke P. Efficacy and safety of intravenous lidocaine for postoperative analgesia and recovery after surgery: a systematic review with trial sequential analysis. Br J Anaesth. 2016 Jun;116(6):770-83. doi: 10.1093/bja/aew101.

  PMID: 27199310 BACKGROUND

• Loftus RW, Yeager MP, Clark JA, Brown JR, Abdu WA, Sengupta DK, Beach ML. Intraoperative ketamine reduces perioperative opiate consumption in opiate-dependent patients with chronic back pain undergoing back surgery. Anesthesiology. 2010 Sep;113(3):639-46. doi: 10.1097/ALN.0b013e3181e90914.

  PMID: 20693876 BACKGROUND

• Dinges HC, Otto S, Stay DK, Baumlein S, Waldmann S, Kranke P, Wulf HF, Eberhart LH. Side Effect Rates of Opioids in Equianalgesic Doses via Intravenous Patient-Controlled Analgesia: A Systematic Review and Network Meta-analysis. Anesth Analg. 2019 Oct;129(4):1153-1162. doi: 10.1213/ANE.0000000000003887.

  PMID: 30418234 BACKGROUND

MeSH Terms

Interventions

Nalbuphine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Mahmoud Ahmed Mokhtar Mohamed, resident doctor

CONTACT

+201070099391; Mahmoud.16266103@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Assiut University hospital

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 16, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12