| CTRI Number |
CTRI/2025/08/093580 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the efficacy of only Ketamine and Ketamine - Dexmedetomidine in reducing propofol dose for IV sedation in short gynaecological procedures |
|
Scientific Title of Study
|
Efficacy of Ketamine versus Ketamine – Dexmedetomidine on effect site concentration of propofol target
controlled infusion in short gynaecological procedures – Randomized Controlled 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 |
Nithiyasree S |
| Designation |
1st year Post-graduate |
| Affiliation |
Sri Manakula Vinayagar Medical College Kalitheerthalkuppam Madagadipet Puducherry |
| Address |
Room no 106 Departmment of Anaesthesiology Sri Manakula Vinayagar Medical College Kalitheerthalkuppam Madagadipet Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9597791002 |
| Fax |
|
| Email |
nithiyasree.srini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ranjan R V |
| Designation |
Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College Kalitheerthalkuppam Madagadipet Puducherry |
| Address |
Room no 107 Departmment of Anaesthesiology Sri Manakula Vinayagar Medical College Kalitheerthalkuppam Madagadipet Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9600823772 |
| Fax |
|
| Email |
ranjanrv2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nithiyasree S |
| Designation |
1st year Post-graduate |
| Affiliation |
Sri Manakula Vinayagar Medical College Kalitheerthalkuppam Madagadipet Puducherry |
| Address |
Room no 106 Departmment of Anaesthesiology Sri Manakula Vinayagar Medical College Kalitheerthalkuppam Madagadipet Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9597791002 |
| Fax |
|
| Email |
nithiyasree.srini@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Manakula Vinayagar Medical College Hospital Kalitheerthalkuppam Madagadipet |
| Address |
Sri Manakula Vinayagar Medical College Hospital Kalitheerthalkuppam Madagadipet Puducherry 605107 |
| Type of Sponsor |
Other [Self] |
|
|
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 Nithiyasree S |
Sri Manakula Vinayagar Medical College and Hospital |
Room no: 106, Department of Anaesthesiology, Kalitheerthalkuppam, Puducherry 605107
Pondicherry
PONDICHERRY |
9597791002
nithiyasree.srini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH- Ethics Comittee |
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 |
| Comparator Agent |
Ketamine- Dexmedetomidine- Propofol |
Patients will be given 0.5 mcg/kg of Inj. Dexmedetomidine will be added to 100ml NS solution and given over 10 minutes prior to sedation. Following which Inj. Ketamine 0.75 mg/kg will be given and started on Propofol TCI at baseline effect site concentration of 2.0 mcg/ml. The patient will be assessed every 3 minutes and if required TCI infusion of propofol will be titrated using 0.5 mcg/ml every 3 minutes throughout the procedure
|
| Intervention |
Ketamine- Propofol |
Patients receiving Ketamine at dose of 0.75 mg/kg bolus with Propofol TCI at baseline effect site concentration of 2.0 mcg/ml. The patient will be assessed every 3 minutes and if required TCI infusion of propofol will be titrated using 0.5 mcg/ml every 3 minutes throughout the procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Age 18 – 60 years
Female Gender
Patients posted for elective short gynaecological procedures
ASA Physical Status I to III |
|
| ExclusionCriteria |
| Details |
Refusal to give informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the Effect site concentration of propofol TCI with only ketamine and with ketamine
dexmedetomidine |
Baseline, 3 minutes, 6 minutes, 9 minutes, 12 minutes, 15 minutes, 18 minutes, 21 minutes, 24 minutes, 27 minutes, 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the incidence of intraoperative airway events in both group
To assess the hemodynamics during the procedure in both groups
To assess the recovery time in both groups |
0-30 minutes |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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 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
|
The study will be conducted in the Department of Anesthesiology, Sri Manakula Vinayagar Medical College and Hospital, Puducherry. The study design will be a controlled triple blinded study. Preoperative examination will be done on patients posted for elective short gynaecological procedures with duration lasting 15-30 min to assess for eligibility based on inclusion and exclusion criteria. All eligible participants will be explained about the nature of the study and will be included in the study after obtaining written informed consent. Patient demographic data like age, height, weight, BMI will be recorded. Patients included in the study will be kept on NPO from 10.00 pm on the night prior to surgery and premedicated with T. Pantoprazole 40 mg on the day of surgery advised to be taken with sips of water two hours prior to the procedure. In the operation room, ASA monitors will be attached and baseline heart rate, non-invasive blood pressure, respiratory rate, end-tidal carbon dioxide and peripheral oxygen saturation will be recorded. A 20-G intravenous cannula will be inserted and checked for adequate flow. All patients will be administered oxygen by face mask at 6 L/min. BIS monitoring will be done for monitoring depth of Assessed for eligibility n=90 Allocated to Group A Patient receiving Ketamine with Propofol TCI n=45 Included in analysis n=45 Additional exclusion n=0 Allocated to to Group B Patient receiving Ketamine - Dexmedetomidine with Propofol TCI n = 45 Included in analysis n=45 Additional exclusion n=0 Randomised anesthesia. The study population will be randomly divided into 2 groups with 45 patients in each group. Group A – Patients receiving Ketamine with Propofol TCI Group B – Patients receiving Ketamine – Dexmedetomidine with Propofol TCI Patients will be administered Inj. Glycopyrrolate 5 mcg/kg, Inj. Ondansetron 0.1 mg/kg, Inj. Midazolam 0.02 mg/kg, Inj. Fentanyl 2 mcg/kg. An Anesthesiologist not related to study, administering anesthesia to the patient will prepare a 100 ml Normal saline solution based on the group the patient is allocated. For Group A, 0.5 ml of NS will be added to the 100 ml NS solution and given over 10 min prior to sedation. For Group B, 0.5 mcg/kg Dexmedetomidine will be added to the 100 ml NS solution and given over 10 min prior to sedation. Following which Inj. KETAMINE 0.75mg/kg will be given in both groups and started on Propofol target controlled infusion using Schnider model. The baseline effect site concentration will be set at 2.0 mcg/ml and the patient will be assessed every 3 min for BIS values and Modified Observer’s Alertness sedation scale. The procedure will be started once MOAA/S reaches 0 and if BIS reaches 50-60. A stable sedation with no patient movement and maintenance of airway, oxygenation and hemodynamics will be the primary goal intra-operatively. The TCI infusion of propofol will be titrated using modified Dixon’s up and down method with subsequent titrations done at 0.5 mcg/ml every 3 min. If there is no movement, the TCI effect site concentration will be reduced by 0.5 mcg/ml from the previous setting. If there is movement during the procedure, the procedure will be carried out after 3 min of increasing the effect site concentration by 0.5 mcg/ml from the previous setting. The MOAA/Score, BIS, Effect site concentration and plasma concentration of propofol will be recorded every 3 min. Vital parameters like HR, NIBP, SpO2, RR, ETCO2 will be monitored every 5 min. When there is no chest movement and ETCO2 tracing, it will be considered apnea and duration of apnea if more than 30 seconds will be recorded. When there is chest movement with no ETCO2 tracing, airway obstruction or laryngospasm will be suspected and airway maneuvers will be performed to maintain a patent airway. The requirement of airway maneuvers and the nature of the airway maneuvers or use of oropharyngeal or nasopharyngeal airway will be recorded. The incidence of laryngospasm or bronchospasm will also be noted. If oxygen saturation falls below 94% then bag and mask ventilation will be performed and it will be recorded. The TCI infusion will be stopped after completion of the procedure. Hypotension defined as MAP less than 60 mmHg or decrease in MAP less than 20% of baseline will be noted and treated with IVF bolus and inj. Ephedrine 6mg IV. Bradycardia defined as HR less than 50/min will be treated with Inj. Atropine 0.6 mg IV. The incidence of bradycardia and hypotension will be recorded. Postoperatively time taken for recovery, time interval between cessation of TCI propofol to MOAA/S of 5 when patients could respond readily to name spoken in normal tone will be recorded and the corresponding BIS and effect site concentration of propofol will be noted. The incidence of post-operative nausea, vomiting and emergence delirium will also be documented. |