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Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 04:25:26 GMT)

CTRI Number CTRI/2019/05/019468 [Registered on: 31/05/2019] - Trial Registered Prospectively Last Modified On 30/05/2019 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Drug Surgical/Anesthesia Study Design Randomized, Parallel Group Trial Public Title of Study Comparison of regional cerebral oxygen saturation variations between "sevoflurane" and "propofol" anaesthesia in gynaecological laparoscopic Scientific Title of Comparison of regional cerebral oxygen saturation variations between Sevoflurane and Propofol Study anaesthesia in Gynaecological laparoscopic surgery Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Atul Aman Trial Coordinator (multi-center study) Designation JR Affiliation ipgmer and sskm hospital Address Department of Anaesthesiology, 3rd floor, 244, ipgmer, harish mukherjee road, , Kolkata 700020 Phone 09088955257 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Atul Aman Query) Designation JR Affiliation ipgmer & sskm hospital Address Department of Anaesthesiology, 3rd floor, 244, ipgmer harish mukherjee road, bhowanipore, kolkata Kolkata WEST BENGAL 700020 India Phone 09088955257 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Atul Aman Designation JR Affiliation ipgmer & sskm hospital Address Department of Anaesthesiology, 3rd floor, 244, ipgmer harish mukherjee road, bhowanipore, kolkata Kolkata WEST BENGAL 700020 India

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Phone 09088955257 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Ipgmer and Sskm Hospital Primary Sponsor Primary Sponsor Details Name Ipgmer and Sskm Hospital Address 244, harish mukherjee road, bhowanipore, KOLKATA 700020 Type of Sponsor Government medical college Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr samarendra nath ipgmer and sskm & 9800348376 samui hospital building, 2nd floor, 244, Ipgmer samarendranathsamui and Sskm Hospital, @gmail.com bhowanipore, Kolkata 700020 Kolkata WEST BENGAL Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? IPGMEandRResearchO Approved 27/03/2019 No versightCommittee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Endometriosis, unspecified Patients Female genital prolapse, unspecified Patients Female infertility, unspecified Intervention / Type Name Details Comparator Agent Comparator Agent Sevoflurane Sevoflurane acts as a positive allosteric modulator of the Gaba-a receptor in electrophysiology studies of neurons and recombinant receptors. It also acts as an Nmda receptor antagonist,potentiates glycine receptor currents, and inhibits nAChR and 5-HT3 receptor currents. Dose will be adjusted using Bis monitoring and keeping it between a range of 40-50 while simultaneously monotoring end tidal sevoflurane levels. Comparator Agent Propofol Acts by potentiation of Gaba-a

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receptor activity and therefore acting as a Gaba-a receptor positive allosteric modulator, thereby slowing the channel-closing time, and at high doses, propofol may be able to activate Gaba-a receptors in the absence of Gaba, behaving as a Gaba-a receptor agonist as well. Dose will be adjusted by monitoring Bis levels and maintaining range between 40-50. Infusion pump will be used for delivery. Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 60.00 Year(s) Gender Female Details 1) Adult women undergoing gynaecological laparoscopic surgery under general anaesthesia
2) Age between 18-60years
3) ASA status of I or II
4) BMI <30
Exclusion Criteria Exclusion Criteria Details 1) Patient refusal 2) A history of cerebrovascular disease 3) Patients on antipsychotic drugs 4) History of drug abuse 5) Significant cardiovascular and respiratory diseases 6) Any pre-existing neurological disorders 7) Poorly controlled hypertension 8) Obesity (Body Mass Index >30)

Method of Generating Computer generated randomization Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints rSO2 rSO2 values will be recorded just before pneumoperitoneum in the neutral position (TN), 5 minutes after the pneumoperitoneum (TP), 5 minutes after the Trendelenburg position(TT) and 5 minutes after desufflation in the neutral position(TD). Secondary Outcome Outcome Timepoints MAP, HR, oxygen saturation (SpO2), ETCO2, just before pneumoperitoneum in the neutral end-tidal sevoflurane tension (ETsevo), core position (TN), 5 minutes after the body temperature, Haemoglobin (Hb%), BIS, pneumoperitoneum (TP), 5 minutes after the arterial oxygen partial pressure (PaO2), and Trendelenburg position(TT) and 5 minutes after arterial carbon dioxide partial pressure (PaCO2) desufflation in the neutral position(TD). Target Sample Size Total Sample Size=34 Sample Size from India=34 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial N/A Date of First 01/06/2019

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Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=3 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details Nil Brief Summary Objective of proposed Research:

To compare the changes in rSO2 between propofol and sevoflurane anaesthesia during laparoscopic gynaecological surgery in the Trendelenburg position in adult females of age group 18-60 years.

Expected outcome:

Significantly lower rSO2 values are observed in the propofol group during gynaecological laparoscopic surgery.

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