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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Mahmoud Ahmed Mokhtar Mohamed, resident doctor
- Phone Number: +201070099391
- Email: Mahmoud.16266103@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group 1
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.
|
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.
|
|
Experimental: group 2
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
amount of opioid consumption
Time Frame: 24 hours
|
Total opioid consumption in the postoperative period.
|
24 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Central Nervous System Depressants
- Sensory System Agents
- Analgesics, Non-Narcotic
- Analgesics
- Analgesics, Opioid
- Narcotics
- Neurotransmitter Agents
- Hypnotics and Sedatives
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Adrenergic Agents
- Dexmedetomidine
- Nalbuphine
Other Study ID Numbers
- Free vs Opioid Anesthesia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.