Comparison of the Effectiveness of Intraoperative Intravenous Lidocaine and Intravenous Remifentanil in Postoperative Pain Management in Laparoscopic Cholecystectomy
NCT ID: NCT07312877
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
138 participants
OBSERVATIONAL
2025-04-01
2025-11-30
Brief Summary
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In this prospective observational study, adult patients (ASA I-II) aged over 18 years who provided written informed consent were included. Standard intraoperative monitoring was performed. Anesthesia induction consisted of fentanyl, lidocaine, propofol, and rocuronium, with maintenance using sevoflurane. Hemodynamic parameters were recorded throughout the procedure. For postoperative analgesia, intravenous paracetamol and tramadol were administered before the end of anesthesia.
The primary objective is to evaluate whether intravenous lidocaine provides postoperative analgesic efficacy and recovery quality comparable to remifentanil, and to determine its potential role as an opioid-sparing alternative in laparoscopic cholecystectomy.
Detailed Description
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The study was conducted following approval from the institutional ethics committee, and written informed consent was obtained from all participants. Patients aged over 18 years with an ASA physical status of I-II were included. Standard monitoring (DII and V5 ECG, non-invasive blood pressure, and pulse oximetry) was applied upon arrival in the operating room. General anesthesia was induced with fentanyl (1-2 mcg/kg), lidocaine (1 mg/kg), propofol (2-2.5 mg/kg), and rocuronium (0.6 mg/kg). Anesthesia was maintained with sevoflurane in oxygen/air mixture.
Hemodynamic parameters, including heart rate, systolic, diastolic, and mean arterial pressures, and oxygen saturation (SpO₂), were recorded at baseline and at defined intraoperative intervals. Twenty minutes before the end of the procedure, intravenous paracetamol (15 mg/kg) and tramadol hydrochloride (10 mg/kg) were administered for postoperative analgesia. After emergence from anesthesia, patients were transferred to the post-anesthesia care unit (PACU) and then to the ward once the Aldrete recovery score reached 9.
Postoperative pain intensity was assessed using the Numeric Rating Scale (NRS) at regular intervals for 24 hours. When NRS \> 4, rescue analgesia was administered according to the institutional protocol. The collected data were analyzed to compare intraoperative hemodynamic stability, depth of anesthesia, postoperative recovery characteristics, and analgesic requirements between the lidocaine and remifentanil groups.
The primary hypothesis of this study is that intravenous lidocaine can provide comparable postoperative analgesia to remifentanil, with potential benefits such as improved hemodynamic stability, faster recovery, and fewer opioid-related side effects. The findings may support the use of lidocaine as an effective opioid-sparing alternative in multimodal analgesia protocols for laparoscopic cholecystectomy.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lidocaine Group
Patients received IV lidocaine (1 mg/kg bolus + infusion) during laparoscopic cholecystectomy
Lidocaine
Patients received intravenous lidocaine 1 mg/kg bolus followed by continuous infusion during laparoscopic cholecystectomy.
Remifentanil Group
Patients received IV remifentanil infusion during laparoscopic cholecystectomy
Remifentanil
Patients received intravenous remifentanil infusion during laparoscopic cholecystectomy.
Interventions
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Lidocaine
Patients received intravenous lidocaine 1 mg/kg bolus followed by continuous infusion during laparoscopic cholecystectomy.
Remifentanil
Patients received intravenous remifentanil infusion during laparoscopic cholecystectomy.
Eligibility Criteria
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Inclusion Criteria
* ASA physical status I-II
* Scheduled for elective laparoscopic cholecystectomy under general anesthesia
* Provided written and verbal informed consent
Exclusion Criteria
* Severe cardiovascular, hepatic, or renal disease
* Pregnancy or lactation
* Conversion from laparoscopic to open cholecystectomy
* Refusal to participate
18 Years
ALL
No
Sponsors
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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
OTHER
Responsible Party
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Nilsu GÜNDÜZ
resident doctor
Locations
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Prof. Dr. Cemil Tascıoğlu City Hospital
Istanbul, Istanbul, Turkey (Türkiye)
Countries
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Other Identifiers
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NG269436444.
Identifier Type: -
Identifier Source: org_study_id