| CTRI Number |
CTRI/2024/10/075583 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the recovery between patients receiving Ketamine-Dexmedetomidine infusion
versus Fentanyl- Dexmedetomidine infusion during the surgery |
|
Scientific Title of Study
|
Recovery profile of intraoperative Ketamine-Dexmedetomidine infusion
versus Fentanyl- Dexmedetomidine infusion in patients undergoing General anaesthesia - A Randomised control study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Uthayasankar |
| Designation |
Post graduate |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre, Puducherry |
| Address |
Main OT Complex,2nd floor,Anesthesiology department,Sri Venkateshwaraa Medical College Hospital and Research Centre, Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9047126190 |
| Fax |
|
| Email |
ushan7sp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ChinthavaliSujatha |
| Designation |
Associate Professor |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre, Puducherry |
| Address |
DEPARTMENT OF ANESTHESIA,Sri Venkateshwaraa Medical College Hospital and Research Centre, Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8939012490 |
| Fax |
|
| Email |
sujathachinthavali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Uthayasankar |
| Designation |
Post graduate |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre, Puducherry |
| Address |
Main OT complex, 2nd floor,Anesthesiology department,Sri Venkateshwaraa Medical College Hospital and Research Centre, Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9047126190 |
| Fax |
|
| Email |
ushan7sp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwara Medical College Hospital and Research Centre ,Ariyur,Pondicherry 605102 |
|
|
Primary Sponsor
|
| Name |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
13-A, Pondy Villupuram Main Road, Ariyur, Ariyur, Puducherry 605107 |
| 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 UTHAYASANKAR |
Sri Venkateshwaraa medical college, hospital and research centre |
Main OT complex, 2nd floor,Anesthesiology department ,Sri Venkateshwaraa Medical College Hospital and Research Centre, Puducherry
Pondicherry
PONDICHERRY |
9047126190
ushan7sp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketamine-Dexmedetomidine infusion versus Fentanyl- Dexmedetomidine infusion |
Group A: DK Group -IV Dexmedetomidine(0.5 ug /kg/h)+Ketamine (0.5 mg/kg/h)
Group B: DF Group - IV Dexmedetomidine (0.5 g/kg/h)+Fentanyl 0.5 mg/kg/hr
The parameters observed will be(1) Extubation time, (2)Recovery time, (3)Recovery characteristics
Modified Stewart Recovery Score (MSRS) which includes the following components -
(1)Maintenane of Airway, (2)Level of consciousness and (3)Motor movements. The secondary outcome is to compare the haemodynamic parameters. HR, MAP, Peripheral capillary oxygen saturation (SpO2), EtCO2 will be recorded at 0,5,10,15,20,25,30 mins of induction and thereafter every 15 min throughout the procedure; and also measured after extubation, 5,10,15 mins after extubation.Duration of intervention is from the time of intubation to the time of skin closure. |
| Comparator Agent |
Ketamine-Dexmedetomidine infusion versus Fentanyl- Dexmedetomidine infusion |
The parameters observed will be(1) Extubation time, (2)Recovery time, (3)Recovery characteristics. Extubation time is defined as the time from discontinuation of infusion to extubation. Recovery time is defined as the time from discontinuation of infusion to first response to verbal command. Recovery characteristics will be assessed after extubation using
13
Modified Stewart Recovery Score (MSRS) which includes the following components -
(1)Maintenane of Airway, (2)Level of consciousness and (3)Motor movements. The secondary outcome is to compare the haemodynamic parameters. HR, MAP, Peripheral capillary oxygen saturation (SpO2), EtCO2 will be recorded at 0,5,10,15,20,25,30 mins of induction and thereafter every 15 min throughout the procedure; and also measured after extubation, 5,10,15 mins after extubation . Duration of intervention is from the time of intubation to the time of skin closure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients of either sex from 18-60 years of age undergoing major abdominal or head and neck surgeries. |
|
| ExclusionCriteria |
| Details |
Patient refusal
American Society of Anesthesiology Class 3 and more
Known drug allergy
Heart block
Arrhythmias
Respiratory disorder
Renal & Hepatic dysfunction |
|
|
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 compare the recovery profile between the two groups.ketamine(0.5mg/kg/hr)and dexmedetomidine(0.5mcg/kg/hr) & fentanyl( 0.5mcg/kr/hr) and dexmedetomidine(0.5mcg/kg/hr) in the patients aged between 18 to 60 years undergoing general anesthesia |
0mins,5mins,10mins,15mins,20mins,25mins,30mins,45mins,60mins,75mins,90mins,105mins,120mins
after extubation 5mins,10mins,15mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the hemodynamic parameters between the two groups.ketamine(0.5mg/kg/hr)and dexmedetomidine(0.5mcg/kg/hr) & fentanyl( 0.5mcg/kr/hr) and dexmedetomidine(0.5mcg/kg/hr) in the patients aged between 18 to 60 years undergoing general anesthesia |
0mins,5mins,10mins,15mins,20mins,25mins,30mins,45mins,60mins,75mins,90mins,105mins,120mins
after extubation 5mins,10mins,15mins |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/10/2024 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ushan7sp@gmail.com].
- For how long will this data be available start date provided 23-09-2024 and end date provided 23-02-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The thesis investigates the recovery outcomes associated with two different intraoperative analgesia regimens during general anesthesia: a Ketamine-Dexmedetomidine infusion versus a Fentanyl-Dexmedetomidine infusion. In this randomized controlled study, patients undergoing general anesthesia were divided into two groups, each receiving one of the two infusion combinations. The primary focus was to compare the recovery profiles of the two regimens, including parameters such as time to wakefulness, postoperative pain levels, and any side effects or complications. The study aims to determine which combination provides a better recovery experience for patients in terms of both efficacy and safety. |