Laparoscopic CholecystectomyPhase 4NCT06736496
Comparative Study of Opioid-Free Anesthesia Versus Opioid Anesthesia in Patients Undergoing Laparoscopic Cholecystectomy
A Phase 4 study testing Nalbuphine and Dexmedetomidine in people with Laparoscopic Cholecystectomy, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Nalbuphine and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- o Adults aged 18-65 years.
- Scheduled for elective laparoscopic cholecystectomy.
- ASA Physical Status I-III.
- Provided informed consent.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Nalbuphine, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalbuphineDrug
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.
DexmedetomidineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of opioid consumption
Total opioid consumption in the postoperative period.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Mokhtar Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736496
- Sponsor's protocol ID
- Free vs Opioid Anesthesia
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22546966Collard 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.
PubMed 17959952Weibel 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.
PubMed 27199310Loftus 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.
PubMed 20693876Dinges 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.
PubMed 30418234
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Opioid-Free Anesthesia Versus Opioid Anesthesia in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06736496
- Acronym / sponsor ID
- Free vs Opioid Anesthesia
- Conditions
- Laparoscopic Cholecystectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: Nalbuphinepatients 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 2 | Experimental | Drug: Dexmedetomidinepatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- o Adults aged 18-65 years.
Key exclusion criteria (6 listed)
- patients with a history of alcohol or drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nalbuphinepatients 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 | group 1 |
| Dexmedetomidinepatients 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 | group 2 |
Primary outcome
amount of opioid consumption
Time frame: 24 hours
Total opioid consumption in the postoperative period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Results publication: PubMed 22546966Blaudszun 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.
- Results publication: PubMed 17959952Collard 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.
- Results publication: PubMed 27199310Weibel 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.
- Results publication: PubMed 20693876Loftus 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.
- Results publication: PubMed 30418234Dinges 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nalbuphine and Dexmedetomidine in people with Laparoscopic Cholecystectomy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Ahmed Mokhtar Mohamed, resident doctor (+201070099391, Mahmoud.16266103@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of opioid consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06736496, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.