Effect of Labetalol, Magnesium Sulfate, or Lidocaine on Opioid Consumption During Laparoscopic Cholecystectomy
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAssiut University
About this trial
Laparoscopic cholecystectomy (gallbladder removal) is one of the most common abdominal operations performed worldwide. Despite its minimally invasive approach, up to half of patients experience notable postoperative pain, which often requires opioid painkillers. Reducing perioperative opioid consumption through non-opioid medications helps minimize opioid-related side effects, improve comfort, and enhance postoperative recovery.
The primary purpose of this clinical trial is to compare the pain-relieving and opioid-sparing effects of three intravenous medications (labetalol, magnesium sulfate, and lidocaine) administered during elective laparoscopic cholecystectomy under general anesthesia.
Adult participants aged 18 to 60 years will be randomly assigned to one of three parallel groups:
* Group Lb: Receives intravenous labetalol as an initial loading infusion before induction followed by a continuous infusion during surgery. * Group M: Receives intravenous magnesium sulfate as an initial loading infusion before induction followed by a continuous infusion during surgery. * Group L: Receives intravenous lidocaine as an initial loading infusion before induction followed by a continuous infusion during surgery.
The main outcome measured is total perioperative opioid consumption during surgery and throughout the first 24 postoperative hours. Investigators will also assess hemodynamic parameters (heart rate and blood pressure), blood oxygen levels, postoperative pain intensity scores, surgeon satisfaction, and the occurrence of any adverse effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for elective laparoscopic cholecystectomy under general anesthesia.
Age between 18 and 60 years.
Both male and female patients.
American Society of Anesthesiologists (ASA) physical status class I or II.
Disqualifiers
Patient refusal to provide signed informed consent.
Known allergy, hypersensitivity, or contraindication to lidocaine, labetalol, or magnesium sulfate.
Bronchial asthma or severe obstructive airway disease.
Second- or third-degree atrioventricular (AV) block, severe bradycardia, or uncontrolled heart failure.
Trial design
Design model
Parallel
Treatments tested in this trial
Labetalol
DrugAdministered intravenously with an initial loading dose of 0.25 mg/kg diluted in 100 mL of 0.9% normal saline infused over 15 minutes prior to induction of general anesthesia, followed by a continuous maintenance infusion of 0.5-1.0 mg/kg/h until completion of the surgical procedure.
Magnesium Sulfate
DrugAdministered intravenously with an initial loading dose of 50 mg/kg diluted in 100 mL of 0.9% normal saline infused over 15 minutes prior to induction of general anesthesia, followed by a continuous maintenance infusion of 25 mg/kg/h until completion of the surgical procedure.
Lidocaine
DrugAdministered intravenously with an initial loading dose of 1.5-2.0 mg/kg diluted in 100 mL of 0.9% normal saline infused over 15 minutes prior to induction of general anesthesia, followed by a continuous maintenance infusion of 2.0 mg/kg/h until completion of the surgical procedure.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Group Lb: Labetalol InfusionExperimental treatment 1 intervention
Group B: Group M: Magnesium Sulfate InfusionActive comparator 1 intervention
Group C: Group L: Lidocaine InfusionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total 24-Hour Opioid Consumption
Cumulative amount of intraoperative and postoperative rescue opioids administered, converted to intravenous morphine milligram equivalents (mg).
Time frame
24 hours postoperativelyLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: