Impact of Entropy Monitoring on Anesthetic Consumption and Recovery After Laparoscopic Cholecystectomy
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.
Aperçu de l'étude
Statut
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Muhammad Ali, MBBS
- Numéro de téléphone: +923334214946
- E-mail: muhammadali_waseem@yahoo.com
Lieux d'étude
-
-
-
Islamabad, Pakistan, 44000
- Recrutement
- KRL Hospital Islamabad
-
Contact:
- Dr Humaira Jadoon, MBBS FCPS
- Numéro de téléphone: +92512852333
- E-mail: drhumairajadoon@gmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
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:
|
|
Comparateur actif: 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. |
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). |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sevoflurane Consumption
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Dr Humaira Jadoon, MBBS, FCPS Anesthesia, KRL Hospital, Islamabad
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- KRLHIslamabad
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
There is no plan to make IPD available
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .