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CTRI Number  CTRI/2023/01/049021 [Registered on: 16/01/2023] Trial Registered Prospectively
Last Modified On: 13/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Two Different Drugs To See Effect on Recovery Time IN Laparoscopic Surgery. 
Scientific Title of Study   Comparing Desflurane Vs Sevoflurane For Effect On Recovery Time In Patient Undergoing Laparoscopic Surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Patel Khushbu Sureshbhai 
Designation  3rd Year Resident  
Affiliation  B.J .Medical College,Ahmedabad  
Address  F3,First Floor,Department Of Anaesthesiology,B.J.Medical College,Civil Hospital ,Asarwa ,Ahmedabad.

Ahmadabad
GUJARAT
380016
India 
Phone  8469978124  
Fax    
Email  khushbupatel6868@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrChandresh Shah 
Designation  Assistant Professor  
Affiliation  B.J .Medical College,Ahmedabad  
Address  F3,First Floor,Department Of Anaesthesiology,B.J.Medical College,Civil Hospital ,Asarwa ,Ahmedabad.

Ahmadabad
GUJARAT
380016
India 
Phone  9328972082  
Fax    
Email  csshah298@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrChandresh Shah 
Designation  Assistant Professor  
Affiliation  B.J .Medical College,Ahmedabad  
Address  F3,First Floor,Department Of Anaesthesiology,B.J.Medical College,Civil Hospital ,Asarwa ,Ahmedabad.

Ahmadabad
GUJARAT
380016
India 
Phone  9328972082  
Fax    
Email  csshah298@gmail.com  
 
Source of Monetary or Material Support  
Government of Gujarat  
 
Primary Sponsor  
Name  Health and family welfare department  
Address  7th floor, new sachivalaya,Gandhinagar 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Patel Khushbu Sureshbhai   New Civil Hospital, Asarwa,Ahmedabad   4th and 5th floor, Trauma centre,civil Hospital,Asarwa, Ahmedabad .
Ahmadabad
GUJARAT 
8469978124

khushbupatel6868@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional ethics committee,B.J Medical College and Civil Hospital, Ahmedabad   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (3) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Desflurane   Desflurane (3-6%),50%o2+50%N2o given for 2 hour of duration of surgery. 
Comparator Agent  Sevoflurane  Sevoflurane (1-2%),50%o2+50%N2o given for 2 hour of duration of surgery. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  ASA I,ASA II patients
Patients undergoing Laparoscopic surgeries
Written and informed consent. 
 
ExclusionCriteria 
Details  Patient refusal to participate in study
Those with clinically significant cardiovascular, respiratory, hepatic, renal, neurologic, psychiatric or metabolic disease.
ASA GRADE III and GRADE IV patients
Pregnant women
Morbid obesity
Patients of less than 20 years and more than 50 years of age
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of recovery and hemodynemic stability during inhalation agent administration in laparoscopic . surgery   5min,10min,15min,30min,45min,60min,
75min,90min,120min,150min 
 
Secondary Outcome  
Outcome  TimePoints 
Nausea,vomiting,drowsiness,tachycardia,hypertension,respiratory distress   After extubation 30 min 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 Enrollment (India)   16/01/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   After the study completed. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Sevoflurane is a colourless, volatile, nonflammable liquid with a characteristic mild odour resembling ether. Chemically, sevoflurane constitutes a polyfluorinated methyl-isopropyl compound.


Sevoflurane is stable at room temperature, has a boiling point of 58.6"C and a vapour pressure of inhalational anaesthetic is its blood solubility, expressed by its bloodlgas partition coefficient. With a bloodlgas partition coefficient of 0.69, sevoflurane is less soluble than the older volatile anaesthetic but more soluble than desflurane (0.42) or nitrous oxide (0.47).


SUPRANE (desflurane, USP), a nonflammable liquid administered via vaporizer, is a general inhalation anesthetic. It is (±)1,2,2,2-tetrafluoroethyl difluoromethyl ether.

Desflurane is a colorless, volatile liquid below 22.8°C. Data indicate that desflurane is stable when stored under normal room lighting conditions according to instructions.


Laparoscopic surgeries under general anesthesia are associated with unique hemodynamic changes in the form of increased systemic vascular resistance leading to hypertension that needs increasing anesthesia depth to be controlled.


Inhaled anaesthetics are the most widely used drugs for maintenance of general anaesthesia because of their ease of administration and predictable intraoperative and recovery characteristics.Inhaled anaesthetics allow rapid emergence from anaesthesia because of easy titratability, with inherent neuromuscular blocker potentiating effects.


General anaesthesia using agents like Desflurane or Sevoflurane are beneficial for early recovery especially for ambulatory procedures.

Given the low blood gas partition coefficient of Sevoflurane (0.69) and Desflurane (0.42) a more rapid emergence from anesthesia is expected compared with traditional inhalational agents like Isoflurane.


 
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