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IRCT20260428069192N2 IRCT 2026-08-07 Tehran University of Medical Sciences Opioid-free versus Opioid-based Anesthesia in Laparoscopic Surgery Evaluating the Effect of Opioid-sparing Anesthesia versus Opioid-based Anesthesia on Pain Intensity and Recovery Outcomes after Laparoscopic Surgery 2026-08-02 anticipated 100 Complete https://irct.ir/trial/92132 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients meeting the inclusion criteria, following final confirmation of eligibility (which occurs after preoperative assessments and is typically determined 2–3 days prior to surgery), will be allocated to one of two intervention groups in a 1:1 ratio using simple randomization with a 6-faced die on the day of surgery, after patient transfer to the operating room, but prior to anesthesia induction. Accordingly, an individual independent of the research team will roll the die immediately after patient transfer to the operating room and before any therapeutic intervention, and based on the number shown, the patient will be randomly assigned to one of the two groups (numbers 1, 2, and 3 = Group A; numbers 4, 5, and 6 = Group B). The treatment team will be immediately informed of the patient's group assignment and will apply the anesthesia protocol and treatment regimen appropriate to the intervention or control group. The allocation of each patient will be performed entirely independently of previous allocations, Blinding description: In this study, a full blind design is not feasible because the anesthesiologist must know which drugs to administer to the patient. Therefore, patient and outcome assessor blinding is applied: Patient (Blinded): The patient is unaware of their group assignment (whether they are receiving opioid-based anesthesia or opioid-sparing anesthesia). All drugs are administered in such a way that the patient cannot distinguish the difference. Outcome Assessor (Blinded): The personnel who record pain intensity, nausea and vomiting, Aldrete scores, and other outcomes in the recovery room and surgical ward are not informed of the patient's group. These individuals have no role in the anesthesia process and only collect data according to the study protocol. Anesthesiologist and Anesthesia Technician (Unblinded): These individuals are aware of the patient's group because they need to prepare and administer the appropriate drugs. However, they are not involved in outcome assessment or data analysis. Statistical Analyst (Blinded): The person or team performing the final data analysis will remain unaware of group assignments until the analysis is finalized. Data will be provided using numerical codes without group labels. 4 complications of anaesthesia. Intervention 1: Intervention group(Opioid‑Sparing Anesthesia): Induction Agent: Propofol 2–2.5 mg/kg 10 mg/mL concentration) administered intravenously.Alternative Analgesic for Induction: Low‑dose ketamine 0.2–0.5 mg/kg (, 50 mg/mL concentration) administered intravenously (no fentanyl used during induction).Muscle Relaxant: Rocuronium 0.6 mg/kg (, 10 mg/mL concentration) administered intravenously to facilitate endotracheal intubation.Maintenance: Sevoflurane ( 1–2% concentration in a mixture of oxygen and air) along with a continuous infusion of dexmedetomidine ( 100 µg/2 mL concentration, diluted in normal saline) at a dose of 0.2–0.7 µg/kg/h using a syringe pump. If available per hospital protocol, lidocaine infusion (, 2% or 20 mg/mL concentration) is also added at 1–1.5 mg/kg/h.Local Anesthesia: Port‑site infiltration with 0.25% bupivacaine () 10–15 mL before incision, or transversus abdominis plane (TAP) block with 0.25% bupivacaine if hospital protocol allows.Postoperative Pain Management: Intravenous paracetamol ( 10 mg/mL concentration) 1 gram every 6 hours, and non‑steroidal anti‑inflammatory drugs (e.g., intravenous ketorolac, Temad Pharmaceutical, 30 mg/mL concentration) 30 mg every 8 hours if no contraindication. Opioids (intravenous morphine 2–4 mg) are administered only as rescue medication in case of pain score of 4 or more on the Numerical Rating Scale.Duration of Intervention: All intraoperative medications are administered from induction until the end of anesthesia, and postoperative pain management continues for 24 hours after surgery. Intervention 2: Control Group) Opioid‑Based Anesthesia): Induction Agent: Propofol 2–2.5 mg/kg (Farsus or Kasra Pharmaceutical, 10 mg/mL concentration) administered as intravenous injection.Analgesic for Induction: Fentanyl 1–2 µg/kg ( 50 µg/mL concentration) administered as intravenous injection.Muscle Relaxant: Rocuronium 0.6 mg/kg ( 10 mg/mL concentration) administered intravenously to facilitate endotracheal intubation.Maintenance: Sevoflurane (1–2% concentration in a mixture of oxygen and air) along with additional fentanyl boluses 0.5–1 µg/kg if heart rate or blood pressure increases by more than 20% from baseline.Postoperative Pain Management: Intravenous paracetamol ( 10 mg/mL concentration) 1 gram every 6 hours, and if needed, intravenous morphine ( 10 mg/mL concentration) 2–4 mg as rescue medication in case of pain score of 4 or more on the Numerical Rating Scale. No - There is not a plan to make this available Justification or reason for not sharing IPD is All data will remain confidential in accordance with the ethical commitment, and only aggregated group-level results will be published in the form of a final article or report.
public Mohamad Sorani
No. 17, Bastani Parizi Alley, Ghods St., Enghelab Ave., Enghelab Sq., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1417744361 +98 21 8898 3025 mohamad.sorani@gmail.com Tehran University of Medical Sciences scientific Mohamad Sorani
No. 17, Bastani Parizi Alley, Ghods St., Enghelab Ave., Enghelab Sq., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1417744361 +98 21 8898 3025 mohamad.sorani@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) AgeBetween 18 and 65 years (both sexes) Physical Status: Class I or II (American Society of Anesthesiologists classification) Elective laparoscopic surgery, including:Laparoscopic cholecystectomyGynecologic laparoscopic surgeryOther general laparoscopic procedures performed under general anesthesia Informed Consent: Ability to understand the study procedures and provide written informed consent 18 years 65 years Both Physical Status Class III or higher History of allergy or contraindication to any drug used in either anesthetic technique Opioid abuse or chronic narcotic use Significant cardiopulmonary, hepatic, or renal disease Pregnancy or lactation Cognitive impairment or psychiatric illness that could compromise postoperative assessment Body Mass Index (BMI) > 35 kg/m² (if considered a confounding factor) T88.5 Other complications of anaesthesia Treatment - Drugs Treatment - Drugs Intervention group(Opioid‑Sparing Anesthesia): Induction Agent: Propofol 2–2.5 mg/kg 10 mg/mL concentration) administered intravenously.Alternative Analgesic for Induction: Low‑dose ketamine 0.2–0.5 mg/kg (, 50 mg/mL concentration) administered intravenously (no fentanyl used during induction).Muscle Relaxant: Rocuronium 0.6 mg/kg (, 10 mg/mL concentration) administered intravenously to facilitate endotracheal intubation.Maintenance: Sevoflurane ( 1–2% concentration in a mixture of oxygen and air) along with a continuous infusion of dexmedetomidine ( 100 µg/2 mL concentration, diluted in normal saline) at a dose of 0.2–0.7 µg/kg/h using a syringe pump. If available per hospital protocol, lidocaine infusion (, 2% or 20 mg/mL concentration) is also added at 1–1.5 mg/kg/h.Local Anesthesia: Port‑site infiltration with 0.25% bupivacaine () 10–15 mL before incision, or transversus abdominis plane (TAP) block with 0.25% bupivacaine if hospital protocol allows.Postoperative Pain Management: Intravenous paracetamol ( 10 mg/mL concentration) 1 gram every 6 hours, and non‑steroidal anti‑inflammatory drugs (e.g., intravenous ketorolac, Temad Pharmaceutical, 30 mg/mL concentration) 30 mg every 8 hours if no contraindication. Opioids (intravenous morphine 2–4 mg) are administered only as rescue medication in case of pain score of 4 or more on the Numerical Rating Scale.Duration of Intervention: All intraoperative medications are administered from induction until the end of anesthesia, and postoperative pain management continues for 24 hours after surgery. Control Group) Opioid‑Based Anesthesia): Induction Agent: Propofol 2–2.5 mg/kg (Farsus or Kasra Pharmaceutical, 10 mg/mL concentration) administered as intravenous injection.Analgesic for Induction: Fentanyl 1–2 µg/kg ( 50 µg/mL concentration) administered as intravenous injection.Muscle Relaxant: Rocuronium 0.6 mg/kg ( 10 mg/mL concentration) administered intravenously to facilitate endotracheal intubation.Maintenance: Sevoflurane (1–2% concentration in a mixture of oxygen and air) along with additional fentanyl boluses 0.5–1 µg/kg if heart rate or blood pressure increases by more than 20% from baseline.Postoperative Pain Management: Intravenous paracetamol ( 10 mg/mL concentration) 1 gram every 6 hours, and if needed, intravenous morphine ( 10 mg/mL concentration) 2–4 mg as rescue medication in case of pain score of 4 or more on the Numerical Rating Scale. Postoperative Pain Intensity (NRS): atient-reported pain intensity on a numerical rating scale from 0 to 10 (0 = no pain, 10 = worst imaginable pain). Timepoint: NRS score recorded at PACU arrival, 30 min, 1, 2, 4, 6, 12, and 24 hours postoperatively. Method of measurement: Numerical Rating Scale (0–10)Description: The patient reports their pain intensity on a scale from 0 (no pain) to 10 (worst imaginable pain). Incidence of Adverse Events: Occurrence of any adverse event related to anesthesia or administered drugs during the first 24 hours after surgery. Timepoint: First 24 hours after surgery. Method of measurement: Clinical recording by a blinded assessor based on predefined criteria. Intraoperative Hemodynamic Parameters: Changes in the patient's vital signs during surgery, including heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure. Timepoint: pre‑induction- Post‑induction - Post‑intubation- 5 minutes after pneumoperitoneum- 30 minutes after pneumoperitoneum- After exsufflation (gas removal)- End of surgery (wound closure)- PACU Arrival15 minutes post‑operation - 30 minutes post‑operation - 60 minutes post‑operation. Method of measurement: Recorded using standard hospital monitoring (electrocardiography, non‑invasive blood pressure monitor, and pulse oximetry) at predefined time points. Total opioid consumption in first 24 hours. Timepoint: The total amount of opioid consumption during the first 24 hours after surgery. Method of measurement: The total amount of opioid consumption (both as regular scheduled doses and as rescue medication) during the first 24 hours after surgery will be calculated in milligrams and recorded according to the type of opioid administered. Tehran University of Medical Sciences Approved 2026-08-02 Research Ethics Committees of School of Public Health & Allied Medical Sciences- Tehran University o No. 17, Mohammad Ebrahim Bastani Parizi Alley, Qods Street, Enghelab Street, Enghelab Square, Tehran, Iran tehran Tehran Iran (Islamic Republic of)