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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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 groups in NCT06231992
Study groupRoleWhat they receive
opioid based anesthesiaActive comparatorI.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 anesthesiaActive 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.

  1. 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.

  1. First posted30 Jan 2024
  2. Study start31 Jan 2024 (estimated)
  3. Primary completionJun 2024 (estimated)
  4. Study completionJul 2024 (estimated)

Resources

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)
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

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.

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