| 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
|
|
|
Primary Sponsor
|
| Name |
Health and family welfare department |
| Address |
7th floor, new sachivalaya,Gandhinagar |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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 |
|
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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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