Entropy Device and How Will Muscle Relaxants Affect itNCT07847788
Impact of Entropy Monitoring on Anesthetic Consumption and Recovery After Laparoscopic Cholecystectomy
A study testing Entropy Monitoring-Guided Anesthesia Titration and Standard Clinical Parameter-Guided Anesthesia Titration in people with Entropy Device and How Will Muscle Relaxants Affect it, run by KRL Hospital, Islamabad at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Entropy Device and How Will Muscle Relaxants Affect it
- What is being tested?
- Entropy Monitoring-Guided Anesthesia Titration and Standard Clinical Parameter-Guided Anesthesia Titration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I or II
- Elective laparoscopic cholecystectomy under GA
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
KRL Hospital Islamabad
Islamabad, 44000
Dr Humaira Jadoon, MBBS FCPS, +92512852333, drhumairajadoon@gmail.com
About this study
Official title: 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:
Read more
- 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.
- Being tested
- Entropy Monitoring-Guided Anesthesia Titration, Standard Clinical Parameter-Guided Anesthesia Titration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entropy Monitoring-Guided Anesthesia TitrationDevice
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:
- Response Entropy (RE) and State Entropy (SE) target values strictly between 40 and 60 throughout the surgical procedure.
- A Response-State Entropy difference (RE-SE) of less than 10.
Standard Clinical Parameter-Guided Anesthesia TitrationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Group A: Entropy Monitored Group | Experimental | 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 Receives: Device: Entropy Monitoring-Guided Anesthesia Titration |
| Group B: Clinically Monitored Group | Active comparator | 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. Receives: Other: Standard Clinical Parameter-Guided Anesthesia Titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sevoflurane Consumption
Total volume of liquid sevoflurane vaporized and delivered to the patient per hour. Automatically recorded by the GE Carestation 650 workstation
Measured: 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
Measured: From discontinuation of sevoflurane gas up to 60 minutes post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Jul 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Entropy Device and How Will Muscle Relaxants Affect itStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KRL Hospital, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Ali, KRL Hospital, Islamabad
- Investigators
- Dr Humaira Jadoon, MBBS, FCPS Anesthesia, Study chair, KRL Hospital, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847788
- Sponsor's protocol ID
- KRLHIslamabad
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Entropy Monitoring on Sevoflurane Consumption and Recovery From General Anesthesia in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07847788
- Acronym / sponsor ID
- KRLHIslamabad
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- KRL Hospital, IslamabadUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Entropy Monitored Group | Experimental | Device: Entropy Monitoring-Guided Anesthesia TitrationDevice/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 |
| Group B: Clinically Monitored Group | Active comparator | Other: Standard Clinical Parameter-Guided Anesthesia TitrationStandard 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA I or II
- Elective laparoscopic cholecystectomy under GA
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entropy Monitoring-Guided Anesthesia TitrationParticipants 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. | Device | Group A: Entropy Monitored Group |
| Standard Clinical Parameter-Guided Anesthesia TitrationParticipants 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). | Other | Group B: Clinically Monitored Group |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No. There is no plan to make IPD available
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Humaira Jadoon, MBBS, FCPS Anesthesia study chair
KRL Hospital, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Entropy Monitoring-Guided Anesthesia Titration and Standard Clinical Parameter-Guided Anesthesia Titration in people with Entropy Device and How Will Muscle Relaxants Affect it, run by KRL Hospital, Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Ali, MBBS (+923334214946, muhammadali_waseem@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sevoflurane Consumption (time frame: End of surgery (from induction of anesthesia until gas discontinuation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.