| CTRI Number |
CTRI/2024/06/068859 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| 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 recovery profile of desflurane vs sevoflurane in FESS surgery |
|
Scientific Title of Study
|
Comparison of recovery profile of Desflurane Vs Sevoflurane in patients undergoing FESS surgery under General Anaesthesia
|
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Birva Khara |
| Designation |
Professor |
| Affiliation |
Pramukh Swami Medical College,Bhaikaka university |
| Address |
Department of Anaesthesiology, Pramukhswami Medical college, Shree Krishna Hospital, Karamsad
Anand GUJARAT 388325 India |
| Phone |
9537122077 |
| Fax |
|
| Email |
Birvank@charutarhealth.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shreyani Chaudhari |
| Designation |
Resident Doctor, Department of Anesthesiology |
| Affiliation |
Pramukh Swami Medical College , Bhaikaka University |
| Address |
Department of Anaesthesiology, Pramukhswami Medical college, Shree Krishna Hospital, Karamsad
Anand GUJARAT 388325 India |
| Phone |
8758562489 |
| Fax |
|
| Email |
cshreyanee@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shreyani Chaudhari |
| Designation |
Resident Doctor, Department of Anesthesiology |
| Affiliation |
Pramukh Swami Medical College,Bhaikaka university |
| Address |
Department of Anaesthesiology, Pramukhswami Medical college, Shree Krishna Hospital, Karamsad
Anand GUJARAT 388325 India |
| Phone |
8758562489 |
| Fax |
|
| Email |
cshreyanee@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology
Shree Krishna Hospital
Pramukh Swami Medical College
Gokal Nagar
Karamsad, Dist. Anand
Gujarat,India,PIN CODE 388325 |
|
|
Primary Sponsor
|
| Name |
Shree Krishna Hospital Anand |
| Address |
Karamsad, Anand, Gujrat ,India ,Pin code 388325 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Birva Khara |
Pramukh Swami Medical College |
Department of anaesthesiology, Pramukh Swami Medical College Anand GUJARAT Anand GUJARAT |
9537122077
Birvank@charutarhealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaikaka University,Kar amsad,Anand,Gujarat-3 88325 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Desflurane |
In Group D patients, anaesthesia will be maintained with oxygen, air and Desflurane through closed circuit via mechanical ventilation till end of surgery. |
| Comparator Agent |
Sevoflurane |
in Group S patients anaesthesia will be maintained with oxygen, air and Sevoflurane through closed circuit via mechanical ventilation till end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients of all age group undergoing FESS surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1)Patients having history of mental dysfunction
2)Discontinuation of inhalation agent intraoperatively due to severe hypotension |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the recovery profile in patients undergoing FESS surgery under general anaesthesia |
post operative period 0 to 6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="38" Sample Size from India="38"
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)
|
24/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patient undergoing FESS surgery under general anesthesia will be recruited to participate in this study. In group D Desflurane will be used as inhalation agent and In group S Sevoflurane willbe used as inhalation agent. Preoperative assessment will be done and written informed consent will be obtained from all the patients who fulfil the inclusion criteria. Patients will be randomly assigned to any one of the two groups. In the preoperative room, after confirming the NBM hours and checking the vitals, both the groups will receive loading dose of injection Dexmedetomidine 1 mcg/kg over 20 minutes in preoperative room and continued intraoperatively in the dose of 0.2mcg-0.7mcg/kg/hr according to hemodynamics. In the operation theatre, after attaching monitors, premedication with injection Fentanyl 2 mcg/kg and injection Loxicard 2% 1.5 mg/kg intravenously will be given before the procedure. Induction for both groups will be achieved by Injection Propofol 2 mg/kg iv . After performing check ventilation, succinyl choline 2 mg/kg will be administered intravenously to both groups to aid in intubation. Oral intubation will be done with PC ETT of appropriate size through conventional laryngoscope. Intermediate muscle relaxation will be achieved with Vecuronium 0.1 mg/kg. Throat pack will be inserted. For maintenance of anaesthesia, In Group D patients, anaesthesia will be maintained with oxygen, air and Desflurane, and in Group S patients anaesthesia will be maintained with oxygen, air and Sevoflurane. Intraoperative muscle relaxation will be maintained with Vecuronium 0.05 mg/kg. The initial inspired concentration of desflurane and sevoflurane will be adjusted to maintain MAP value less than 20% of baseline value . Oxygen saturation and end tidal carbon dioxide values will be monitored continuously. Heart rate, blood pressure will be recorded every 5 min during surgery. Injection ondansetron 4 mg and Injection Paracetamol 1 gm iv will be given at end of surgery. Sevoflurane/desflurane will be discontinued at the end of surgery and time will be noted, throat pack will be removed and 100% oxygen will be delivered. Residual neuromuscular blockade will be reversed using Glycopyrrolate 0.01mg/kg iv and Neostigmine 0.05 mg/kg iv. The times from discontinuing inhalation agent to eye opening, tracheal extubation, obeying verbal commands, as well as the time to orientation to name will be assessed at 30-60 s intervals. The duration of anesthesia and surgery will be recorded. On arrival in recovery room, heart rate, blood pressure and oxygen saturation will be monitored until the patient is fully awake. If required iv analgesic will be given for post operative pain relief. The modified Aldrete scoring system will be used to access recovery from anesthesia.The modified Aldrete scores will be evaluated every 10 min after arrival in recovery room for the first half hour then every 15 or 30 mins until discharge. The time to achieve modified Aldrete Score >9 after discontinuation of the inhalation agent will be noted. |