| CTRI Number |
CTRI/2024/08/072024 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of ketodex and dexmedetomidine sedation for ear surgery |
|
Scientific Title of Study
|
Comparison of ketamine-dexmedetomidine and dexmedetomidine infusion in middle ear surgeries under
monitored anesthesia care. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nirali Nimeshkumar Panchal |
| Designation |
Professor |
| Affiliation |
Pramukhswami medical college |
| Address |
Department of anaesthesiology, Pramukhswami medical college, Karamsad, Anand
Anand GUJARAT 388315 India |
| Phone |
09825031808 |
| Fax |
|
| Email |
dr.niralipanchal@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Nirali Panchal |
| Designation |
Professor |
| Affiliation |
PRAMUKHSWAMI MEDICAL COLLEGE, BHAIKAKA UNIVERSITY |
| Address |
Department of anaesthesiology, Pramukhswami medical college, Karamsad, Anand
Anand GUJARAT 388315 India |
| Phone |
09825031808 |
| Fax |
|
| Email |
dr.niralipanchal@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Pradip Asari |
| Designation |
2nd year anesthesia resident |
| Affiliation |
Pramukhswami medical college |
| Address |
Department of anaesthesiology, Pramukhswami medical college, Karamsad, Anand
Anand GUJARAT 388325 India |
| Phone |
917990599017 |
| Fax |
|
| Email |
asaripradip8524@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pramukhswami medical college, Karamsad, Anand, Gujarat, India, 388325 |
|
|
Primary Sponsor
|
| Name |
Pramukhswamu medical college |
| Address |
Pramukhswami medical college, Karamsad, Anand, Gujarat, India, 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 Nirali Panchal |
Pramukhswami medical college Shree Krishna hospital |
Department of anaesthesiology Pramukhswami medical college Karamsad Anand Anand GUJARAT |
09825031808
dr.niralipanchal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee-2 Bhaikaka University karamsad Anand Gujarat |
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 |
Inj. Ketamine and Inj. Dexmedetomidine |
Infusion of 50 mg (1 ml) of ketamine and 50 mcg (1 ml) of dexmedetomidine will be diluted in 23ml
of normal saline (NS). Patient will receive a loading dose of ketamine 0.5 mg/kg, dexmedetomidine 0.5mcg/kg
over 10 min, followed by a maintenance dose of ketamine 0.3 mg/kg/h and dexmedetomidine 0.3 mcg/kg/h. |
| Comparator Agent |
Inj.Dexmedetomidine |
Infusion of 50 mcg (1 ml) of dexmedetomidine will be diluted in 24ml of normal saline. Patient will
receive a loading dose of 0.5mcg/kg, followed by a maintenance dose of 0.3 mcg/kg/hr. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anesthesiologists (ASA) Grade 1 to 3
o Patients undergoing middle ear surgeries under MAC |
|
| ExclusionCriteria |
| Details |
Patients undergoing middle ear surgeries under General Anaesthesia
Known allergic to study medications
Patients with renal dysfunction
Patients with heart rate below 60/min
Pregnant patient
History of taking sedative or opioid medication since last one month
Known neurological or neuromuscular disorders
Bmi equal to more than 30 kg/m2 |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assess the onset time of sedation of inj. ketamine - dexmedetomidine and inj.dexmedetomidine during Monitor
Anaesthesia care for middle ear surgeries. |
baseline, every 1 minutes till ramsay sedation score is 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess the intra-operative hemodynamic (Heart rate, Mean arterial pressure) |
During surgery |
| Assess recovery time |
After surgery |
| Assess surgeon satisfaction |
after surgery |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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)
|
15/08/2024 |
| 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 - NO
|
|
Brief Summary
|
Pre-anaesthetic check-ups will be conducted on all the patients before the surgery. Patients will be counselled for sedation, use of local anaesthesia and the details of the operative procedure. Patients will be kept nil by mouth 8 hours for solid and 2 hours for clear liquid. On the day of surgery non-invasive blood pressure, pulse oximetry, electrocardiogram will be attached and baseline parameters will be recorded. Oxygen supplementation will be given using a face mask. Inj. Glycopyrolate 0.2mg and inj. Midazolam 0.02 mg/kg will be given. Group allocation will be done using opaque envelope method. Sedation will be started according to group allocation. Group KD: Infusion of 50 mg (1 ml) of ketamine and 50 mcg (0.5 ml) of dexmedetomidine will be diluted in 23ml of normal saline (NS). Patient will receive a loading dose of ketamine 0.5 mg/kg, dexmedetomidine 0.5mcg/kg over 10 min, followed by a maintenance dose of ketamine 0.3 mg/kg/h and dexmedetomidine 0.3 mcg/kg/h. Group D: Infusion of 50 mcg (1 ml) of dexmedetomidine will be diluted in 24ml of normal saline. Patient will receive a loading dose of 0.5mcg/kg, followed by a maintenance dose of 0.3 mcg/kg/hr. After starting sedation, when Modified Ramsay Sedation- 3 (no spontaneous eye opening, response to vocal stimulus) achieved this time will be noted as onset time of sedation (primary objective of the study) surgeon will be allowed to give local anaesthesia infiltration. The heart rate, mean arterial blood pressure, sedation score will be monitored every 10 minutes. Heart rate less than 60/min will be considered as bradycardia and will be treated with inj. Glycopyrrolate. Systolic blood pressure less than 20% of base line will be consider as hypotension and will be treated with fluid challenge and inj. Mephentermine 6mg. Infusion will be increased for fall in Modified Ramsay Sedation score less than 3 and vice versa. Nausea- vomiting will be treated with inj. Ondansetron 8mg. Desaturation(SpO2 < 94%) will be manage with increasing oxygen supplement, nasopharyngeal airway, bag and mask ventilation. If desaturation persist patient will be intubated. And such patients will be excluded from the study. Once the surgery will complete the surgery, patient will be shifted to post anaesthesia care unit (PACU) and postoperative recovery and PACU discharge readiness will be assess using modified Aldrete score and time will be noted. Postoperative analgesia will be assessed by VAS score before shifting patient to PACU and if score more than 4. inj. Paracetamol 1gm will be given. Surgeon satisfaction according to likert scale (poor, good, excellent) will be recorded. |