| CTRI Number |
CTRI/2024/07/070550 [Registered on: 13/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Dexmedetomidine and Sevoflurane on the quality of recovery and cognitive function after general anaesthesia |
|
Scientific Title of Study
|
Comparison of Dexmedetomidine and Sevoflurane on the quality of recovery and cognitive function after general anaesthesia: A Randomised Single Blinded clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mamta Kushwaha |
| Designation |
Junior resident |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
Department of anaesthesiology and critical care, Uttar Pradesh university of medical sciences,Saifai,
Etawah
UTTAR PRADESH
206130
India
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7607664391 |
| Fax |
|
| Email |
mamtakushwaha170@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha shukla |
| Designation |
Professor & HOD |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
Department of anaesthesiology and critical care ,Uttar Pradesh University of medical sciences,Saifai,
Etawah
UTTAR PRADESH
206130
India
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9412201915 |
| Fax |
|
| Email |
ushashukla1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Kushwaha |
| Designation |
Junior Resident |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
Department of anaesthesiology and critical care Uttar Pradesh university of medical sciences, Saifai,
Etawah
UTTAR PRADESH
206130
India
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7607664391 |
| Fax |
|
| Email |
mamtakushwaha170@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of Medical sciences, saifai Etawah, Pincode-206130,India |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University of Medical sciences |
| Address |
Room 329, Department of Anesthesiology and Critical care, Uttar Pradesh University of Medical sciences,Saifai ,Etawah |
| Type of Sponsor |
Government 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 Mamta Kushwaha |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
Department of
anaesthesiology and
critical care Uttar Pradesh University of medical sciences
Saifai
Etawah
UTTAR PRADESH
Etawah
UTTAR PRADESH |
7607664391
mamtakushwaha170@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Uttar Pradesh University of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Group (D) Patients will receive general anaesthesia using dexmedetomidine with loading dose of 1 mcg/kg in 100 ml NS IV over 10-20 minutes, followed by maintenance IV infusion at rate of 0.4-0.7 mcg/kg/hr IV Infusion to maintain BIS of 40 -60 till the end of surgery. |
| Comparator Agent |
Dexmedetomidine and Sevoflurane |
Sevoflurane is a volatile anesthetic agent. Dexmedetomidine is alpha 2 agonist which has analgesic and sedative effect. |
| Intervention |
Sevoflurane |
Group (S) Patients will recieve general anaesthesia Sevoflurane (0.6-1.5%) dial concentration adjusted to maintain a BIS of 40-60 till the end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult subjects classified as American Society of Anaesthesiologists (ASA) I-II.2.Non-obese individuals with a body mass index (BMI) below 30kg/m2.3.Mini-Mental State Examination(MMSE) score 25 preoperatively.4.Patients undergoing general anaesthesia of more than 2 hours and less than 6 hours at UPUMS hospital. |
|
| ExclusionCriteria |
| Details |
1.Patient refusal.
2.Presence of health conditions(e.g.cardiac, pregnancy, pulmonary diseases,neurological condition)
3.Visual/hearing impairment, smoking/alcohol abuse, cognitive dysfunction.
4.Mini-Mental State Examination (MMSE) score less than 25 preoperatively.
5.Any known allergy to drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Dexmedetomidine and Sevoflurane on QoR-15(Quality of recovery questionnaire) |
Preoperatively (30 min before surgery)
Post-operative Day-1
Post-operative Day -2
At the day of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Comparison of Dexmedetomidine and Sevoflurane on MMSE(Mini mental state examination)
2.Comparison of hemodynamic parameters
3.Comparison of emergence agitation
4.comparison of side effect and any complications |
1.Post-operative Day-1
2.Intraoperatively
3.After two minutes after extubation
4.Intra-operative and Post-operative |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
27/07/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Surgical and anaesthetic procedures may affect a patient’s quality of life, producing a sensation of discomfort, even in the absence of specific complications. In addition, poor postoperative recovery may lead to increased hospital costs and decreased patient satisfaction. Therefore, anaesthesiologists seek techniques that can provide high-quality recovery, minimise the complications, and reduce the time to return to daily activities. The two most commonly used general anaesthesia techniques are total intravenous anaesthesia (TIVA) and balanced general anaesthesia (BGA), with intravenous anaesthesia combined with inhalation anaesthesia. The use of total intravenous anaesthesia (TIVA) has increased recently; this technique has been reported to provide a better experience and higher levels of patient satisfaction in outpatient and inpatient surgeries, possibly because of a lower incidence of pain, agitation, and postoperative nausea and vomiting (PONV). Studies on the quality of postoperative recovery have mainly focused on measures such as recovery time, cardiorespiratory complications, pain, postoperative nausea and vomiting (PONV), hospital length of stay and other complications. Considered in isolation, these factors may be insufficient to explain a patient’s perception of postoperative recovery following general anaesthesia. However, patient-assessed quality of life is an important factor to be considered in this clinical setting.Sevoflurane, a volatile inhalation anaesthetic, is widely utilised in surgical procedures due to its favourable pharmacokinetics. While it provides a reliable depth of anaesthesia, its rapid elimination allows for a relatively prompt recovery. However, concerns have been raised regarding emergence delirium and potential cognitive effects associated with sevoflurane, particularly in vulnerable patient populations. Postoperative cognitive dysfunction (POCD)poses a significant challenge in the realm of general anaesthesia and surgery, particularly affecting patients. This cognitive decline, encompassing memory, mood, and sleep disturbances, presents clinical complexities with repercussions such as prolonged hospitalisation and increased mortality. Although different drugs including opioids, benzodiazepines and clonidine, one kind of alpha 2-adrenoreceptor agonists, have been tried in clinic either as alpha prophylactic measure or treatment, the results have been variable.Among which, dexmedetomidine, a highly specific alpha2-adrenoreceptor agonist (receptor selectivity, alpha 2 / alpha 1 = 1620/1), has sedative and analgesic properties without significant respiratory depression at the clinically approved dosage. Dexmedetomidine emerges as a multifunctional candidate with reported neuroprotective effects. While clinical studies suggest potential benefits, a comprehensive understanding remains elusive. |