Impact of Entropy Monitoring on Anesthetic Consumption and Recovery After Laparoscopic Cholecystectomy

September 23, 2026 updated by: Muhammad Ali, KRL Hospital, Islamabad

Effect of Entropy Monitoring on Sevoflurane Consumption and Recovery From General Anesthesia in Patients Undergoing Laparoscopic Cholecystectomy

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:

  • Does entropy monitoring significantly decrease the mean consumption rate of sevoflurane gas (in mL/hr) compared to traditional clinical monitoring during surgery?
  • Does entropy monitoring significantly reduce the mean recovery time (in minutes to open eyes on verbal command) after discontinuing anesthesia? Researchers will compare patients whose anesthesia depth is guided by real-time entropy monitoring (brainwave and facial muscle sensors) to patients whose anesthesia is guided by standard clinical signs (heart rate and blood pressure) to see if using entropy sensors reduces total anesthetic gas use and enables faster patient recovery.

Participants will:

  • Receive routine pre-medication and general anesthesia induction for elective laparoscopic cholecystectomy.
  • Have continuous monitoring during surgery using either entropy brain/muscle sensors (Group A) or standard clinical vital signs (Group B) to guide the delivery of sevoflurane gas.
  • Have their total sevoflurane gas consumption rate automatically recorded at the end of surgery.
  • Be assessed after surgery for recovery time, measured in minutes from the time sevoflurane is turned off until they open their eyes upon verbal command.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 44000
        • Recruiting
        • KRL Hospital Islamabad
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I or II
  • Elective laparoscopic cholecystectomy under GA

Exclusion Criteria:

  • Emergency cholecystectomy
  • Co Morbid (Hypertension, Diabetes Mellitus, Ischemic Heart Disease, Chronic Kidney Disease, Asthma, Stroke)
  • Known allergy or contraindication to sevoflurane or study drugs
  • Addictions such as chronic use of sedatives, hypnotics or alcohol abuse on medical records
  • BMI of 30 or greater (Obese patients tend to have delated recovery from general anesthesia)
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A: Entropy Monitored Group

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

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.
Active Comparator: Group B: Clinically Monitored Group

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 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sevoflurane Consumption
Time Frame: End of surgery (from induction of anesthesia until gas discontinuation)

Total volume of liquid sevoflurane vaporized and delivered to the patient per hour. Automatically recorded by the GE Carestation 650 workstation
End of surgery (from induction of anesthesia until gas discontinuation)
Recovery Time
Time Frame: From discontinuation of sevoflurane gas up to 60 minutes post-procedure

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
From discontinuation of sevoflurane gas up to 60 minutes post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KRL Hospital, Islamabad

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Dr Humaira Jadoon, MBBS, FCPS Anesthesia, KRL Hospital, Islamabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KRLHIslamabad

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make IPD available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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