An interventional study of Entropy Monitoring-Guided Anesthesia Titration and Standard Clinical Parameter-Guided Anesthesia Titration in Entropy Device and How Will Muscle Relaxants Affect it, sponsored by KRL Hospital, Islamabad. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by KRL Hospital, Islamabad · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if brainwave-guided anesthesia (entropy monitoring) can reduce anesthetic drug consumption and speed up recovery time in adult patients undergoing elective laparoscopic cholecystectomy surgery under general anesthesia.
The main questions it aims to answer are:
Participants will:
KRL Hospital, Islamabad is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device/Protocol: General anesthesia managed with Entropy Monitoring (GE Carestation 650). The anesthesiologist adjusts sevoflurane depth using real-time brain (EEG) and muscle (EMG) signals to maintain Response Entropy (RE) and State Entropy (SE) levels between 40 and 60, keeping the RE-SE difference under 10
Device: Entropy Monitoring-Guided Anesthesia Titration
Standard Care: General anesthesia managed using Standard Clinical Signs. The anesthesiologist adjusts sevoflurane levels based on standard clinical indicators (blood pressure, heart rate within ±20% of baseline, tearing, etc.) without using entropy numbers to guide drug dosing.
Other: Standard Clinical Parameter-Guided Anesthesia Titration
Participants will receive general anesthesia via GE Carestation 650 Anesthesia Workstation equipped with Entropy module, maintained with sevoflurane in oxygen and air. Standard pre-medication (Midazolam 0.01-0.1 mg/kg and Nalbuphine 0.1 mg/kg), induction (Propofol in 10 mg increments), and neuromuscular blockade (Atracurium 0.5 mg/kg with NMT monitoring) will be administered. Anesthetic depth will be continuously monitored using forehead EEG/EMG sensors. The anesthesiologist will titrate the concentration of inhaled sevoflurane to maintain: 1. Response Entropy (RE) and State Entropy (SE) target values strictly between 40 and 60 throughout the surgical procedure. 2. A Response-State Entropy difference (RE-SE) of less than 10.
Participants will receive identical general anesthesia premedication, induction, and airway management protocols (Midazolam, Nalbuphine, Propofol, Atracurium, and maintenance with sevoflurane in oxygen and air) as Group A. Anesthetic depth will be guided strictly using traditional clinical parameters without the aid of entropy numbers. The anesthesiologist will titrate the concentration of inhaled sevoflurane to maintain: Heart rate (HR) within ±20% of the patient's baseline value. Mean Arterial Pressure (MAP) within ±20% of the patient's baseline value. Clinical signs of light anesthesia (e.g., somatic movement, excessive lacrimation, or sweating).
Sevoflurane Consumption
Total volume of liquid sevoflurane vaporized and delivered to the patient per hour. Automatically recorded by the GE Carestation 650 workstation
Time frame: End of surgery (from induction of anesthesia until gas discontinuation)
Recovery Time
Time required for the patient to open their eyes following a verbal command after the flow of sevoflurane gas is turned off at the end of surgery
Time frame: From discontinuation of sevoflurane gas up to 60 minutes post-procedure
Plan to share: No — There is no plan to make IPD available
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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KRL Hospital, Islamabad