Opioid UseNCT06231992
Opioid Free Anaesthesia Versus Opioid Based Anesthesia for Laparscopic Cholecystectomy
A study testing opioid anaesthesia and Opioid free anaesthesia in people with Opioid Use, run by Al-Azhar University.
Trial summary
The aim of this study is to compare the efficacy of Opioid-free anesthesia (OFA) with opioid anaesthesia (OA) in patients undergoing laparoscopic cholecystectomy (LC). Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Opioid Use
- What is being tested?
- opioid anaesthesia and Opioid free anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2024to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- scheduled for laparoscopic cholecystectomy
- american society of anaesthesiologists' physical status ǀ and ǁ
- body mass index less than 30
Who cannot join
- Patients with uncontrolled hypertension and Diabetes mellitus.
- Patient's currently taking opioid for chronic pain.
- Patients with allergies to study medication.
- Patients with cardiorespiratory disorder.
- Patients with hepatic and renal insufficiency
About this study
Official title: Comparative Study Between Opioid Free Anaesthesia Versus Opioid Based Anesthesia for Laparscopic Cholecystectomy
The aim of this study is to compare the efficacy of Opioid-free anesthesia (OFA) with opioid anaesthesia (OA) in patients undergoing laparoscopic cholecystectomy (LC).
Read the detailed description
Laparoscopic Cholecystectomy (LC) is a standard surgical procedure for cholelithiasis and gallstone disease, became rapidly the procedure of choice for gallbladder disease and It decreases postoperative pain, decreases the need for postoperative analgesia, shortens the hospital stay, and returns the patient to full activity within 1 week (compared with 1 month after open cholecystectomy). LC also provides less scars and improved patient satisfaction as compared with open cholecystectomy Pneumoperitoneum is created using Carbon dioxide, and a camera and dissecting instruments are introduced in the abdominal cavity. Initiation and maintenance of pneumoperitoneum cause hemodynamic stress, which is attenuated by adequate anesthesia depth and often multimodal analgesia. Although laparoscopic cholecystectomy is a standard minimally invasive surgical procedure, some patients may have significant morbidity in the first 24 to 72 hours during the postoperative period Opioids are commonly used for intraoperative analgesia and sedation during general anesthesia and are among the most widely used agents for treating acute pain in the immediate postoperative period. Opioids are known to provide adequate analgesia and stable intraoperative hemodynamics, which are the most critical concerns during the perioperative period. Although opioids are an essential constituent of balanced anesthesia, their use has been questioned due to severe and significant adverse effects Moreover, the availability of potent opioids in low-resource settings is also a remarkable challenge. To tackle this situation several suitable alternatives were explored. Preemptive and multimodal analgesia is an established care model that minimizes perioperative opioid consumption, thereby minimizing adverse effects and promoting positive outcomes after surgery These techniques combine the pharmacologic effects of multiple analgesics to achieve a synergistic effect of their different modes of action and curtail individual drug doses, thereby minimizing their side effects, Opioid-free anesthesia (OFA) Sympathetic and parasympathetic suppression can be achieved today with loco-regional anaesthesia or by several non-opioid drugs. Opioid free general anaesthesia can be achieved with 50 mg ketamine given after propofol and before incision in spontaneous breathing patients like for plastic surgery .The alpha-2agonists , suppress better the sympathetic system and can replace opioids for sympathetic stabilization in major surgery
- Conditions
- Opioid Use
- Being tested
- opioid anaesthesia, Opioid free anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioid anaesthesiaProcedure or surgery
I.V Fentanyl (1-2ug/kg) before induction of general anesthesia with I.V propofol (1-2mg/kg), atracurium (0.5mg/kg). Intermittent boluses of fentanyl will be given intraoperatively when needed to maintain the change in hemodynamics within 20 % of the baseline.
Opioid free anaesthesiaProcedure or surgery
- IV Ketamine (0.25-0.5 mg/kg) before induction of general anesthesia with I.V propofol (1-2 mg/kg), atracurium (0.5mg/kg) followed by(0.25mg /min) infusion of ketamine for maintenance
- Dexamethasone I.V (8 mg) will be given before induction of general anesthesia.
- magnesium sulphate (20 mg/kg)in 100ml saline within 10 mints Followed by infusion of magnesium sulphate at rate of (10mg/kg/h).
| Study group | Role | What they receive |
|---|---|---|
| opioid based anesthesia | Active comparator | I.V Fentanyl (1-2ug/kg) before induction of general anesthesia with I.V propofol (1-2mg/kg), atracurium (0.5mg/kg). Intermittent boluses of fentanyl will be given intraoperatively when needed to maintain the change in hemodynamics within 20 % of the baseline. Receives: Procedure: opioid anaesthesia |
| opioid free anesthesia | Active comparator | - IV Ketamine (0.25-0.5 mg/kg) before induction of general anesthesia with I.V propofol (1-2 mg/kg), atracurium (0.5mg/kg) followed by(0.25mg /min) infusion of ketamine for maintenance. Dexamethasone I.V (8 mg) will be given before induction of general anesthesia. magnesium sulphate (20 mg/kg)in 100ml saline within 10 mints Followed by infusion of magnesium sulphate at rate of (10mg/kg/h). Receives: Procedure: Opioid free anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score
assessment of postopeative pain after laparoscopic cholecystectomy Score ranging from 0 to 10. 0 = the best , 10= the worst
Measured: first postoperative day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start31 Jan 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Gomaa, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231992
- Sponsor's protocol ID
- Anesthesia for cholecystectomy
- Status last verified
- Jan 2024
- First submitted
- 27 Dec 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Opioid Free Anaesthesia Versus Opioid Based Anesthesia for Laparscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06231992
- Acronym / sponsor ID
- Anesthesia for cholecystectomy
- Conditions
- Opioid Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 31 Jan 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 30 Jan 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.
The aim of this study is to compare the efficacy of Opioid-free anesthesia (OFA) with opioid anaesthesia (OA) in patients undergoing laparoscopic cholecystectomy (LC).
Detailed description
Laparoscopic Cholecystectomy (LC) is a standard surgical procedure for cholelithiasis and gallstone disease, became rapidly the procedure of choice for gallbladder disease and It decreases postoperative pain, decreases the need for postoperative analgesia, shortens the hospital stay, and returns the patient to full activity within 1 week (compared with 1 month after open cholecystectomy). LC also provides less scars and improved patient satisfaction as compared with open cholecystectomy Pneumoperitoneum is created using Carbon dioxide, and a camera and dissecting instruments are introduced in the abdominal cavity. Initiation and maintenance of pneumoperitoneum cause hemodynamic stress, which is attenuated by adequate anesthesia depth and often multimodal analgesia. Although laparoscopic cholecystectomy is a standard minimally invasive surgical procedure, some patients may have significant morbidity in the first 24 to 72 hours during the postoperative period Opioids are commonly used for intraoperative analgesia and sedation during general anesthesia and are among the most widely used agents for treating acute pain in the immediate postoperative period. Opioids are known to provide adequate analgesia and stable intraoperative hemodynamics, which are the most critical concerns during the perioperative period. Although opioids are an essential constituent of balanced anesthesia, their use has been questioned due to severe and significant adverse effects Moreover, the availability of potent opioids in low-resource settings is also a remarkable challenge. To tackle this situation several suitable alternatives were explored. Preemptive and multimodal analgesia is an established care model that minimizes perioperative opioid consumption, thereby minimizing adverse effects and promoting positive outcomes after surgery These techniques combine the pharmacologic effects of multiple analgesics to achieve a synergistic effect of their different modes of action and curtail individual drug doses, thereby minimizing their side effects, Opioid-free anesthesia (OFA) Sympathetic and parasympathetic suppression can be achieved today with loco-regional anaesthesia or by several non-opioid drugs. Opioid free general anaesthesia can be achieved with 50 mg ketamine given after propofol and before incision in spontaneous breathing patients like for plastic surgery .The alpha-2agonists , suppress better the sympathetic system and can replace opioids for sympathetic stabilization in major surgery
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opioid based anesthesia | Active comparator | Procedure: opioid anaesthesiaI.V Fentanyl (1-2ug/kg) before induction of general anesthesia with I.V propofol (1-2mg/kg), atracurium (0.5mg/kg). Intermittent boluses of fentanyl will be given intraoperatively when needed to maintain the change in hemodynamics within 20 % of the baseline. |
| opioid free anesthesia | Active comparator | Procedure: Opioid free anaesthesia- IV Ketamine (0.25-0.5 mg/kg) before induction of general anesthesia with I.V propofol (1-2 mg/kg), atracurium (0.5mg/kg) followed by(0.25mg /min) infusion of ketamine for maintenance. Dexamethasone I.V (8 mg) will be given before induction of general anesthesia. magnesium sulphate (20 mg/kg)in 100ml saline within 10 mints Followed by infusion of magnesium sulphate at rate of (10mg/kg/h). |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- scheduled for laparoscopic cholecystectomy
Key exclusion criteria (5 listed)
- Patients with uncontrolled hypertension and Diabetes mellitus.
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 |
|---|---|---|
| opioid anaesthesiaI.V Fentanyl (1-2ug/kg) before induction of general anesthesia with I.V propofol (1-2mg/kg), atracurium (0.5mg/kg). Intermittent boluses of fentanyl will be given intraoperatively when needed to maintain the change in hemodynamics within 20 % of the baseline. | Procedure or surgery | opioid based anesthesia |
| Opioid free anaesthesia* IV Ketamine (0.25-0.5 mg/kg) before induction of general anesthesia with I.V propofol (1-2 mg/kg), atracurium (0.5mg/kg) followed by(0.25mg /min) infusion of ketamine for maintenance * Dexamethasone I.V (8 mg) will be given before induction of general anesthesia. * magnesium sulphate (20 mg/kg)in 100ml saline within 10 mints Followed by infusion of magnesium sulphate at rate of (10mg/kg/h). | Procedure or surgery | opioid free anesthesia |
Primary outcome
Visual analogue score
Time frame: first postoperative day after surgery
assessment of postopeative pain after laparoscopic cholecystectomy Score ranging from 0 to 10. 0 = the best , 10= the worst
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Opioid Use
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing opioid anaesthesia and Opioid free anaesthesia in people with Opioid Use, run by Al-Azhar 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Jan 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue score (time frame: first postoperative day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2024.