CTRI Number |
CTRI/2020/06/026077 [Registered on: 23/06/2020] Trial Registered Prospectively |
Last Modified On: |
14/08/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
Effect of drug given during spine surgery for old aged patients on Recovery and mentation |
Scientific Title of Study
|
Effect of Intraoperative Dexmedetomidine infusion on Postopearative Cognitive Dysfunction and Recovery Quality in an Elderly Patient posted for Spine Surgery: a Randomized Prospective Double Blinded Study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Inderpreet Singh Walia |
Designation |
DNB Resident Neuroanaesthesia |
Affiliation |
Indraprastha Apollo Hospital |
Address |
Anaesthesia Office , OT Complex 1 , First Floor
South DELHI 110076 India |
Phone |
|
Fax |
|
Email |
inderpreet.inderwalia@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr K J Choudhury |
Designation |
Senior Consultant |
Affiliation |
Indraprastha Apollo Hospital |
Address |
Anaesthesia Office , OT Complex 1 , First Floor
South DELHI 110076 India |
Phone |
|
Fax |
|
Email |
kjchoudhury@samvedana.org |
|
Details of Contact Person Public Query
|
Name |
Dr K J Choudhury |
Designation |
Senior Consultant |
Affiliation |
Indraprastha Apollo Hospital |
Address |
Anaesthesia Office , OT Complex 1 , First Floor
South DELHI 110076 India |
Phone |
|
Fax |
|
Email |
kjchoudhury@samvedana.org |
|
Source of Monetary or Material Support
|
Indraprastha Apollo Hospital New Delhi |
|
Primary Sponsor
|
Name |
Indraprastha Apollo Hospital New Delhi |
Address |
Sarita Vihar New Delhi
110076 |
Type of Sponsor |
Private hospital/clinic |
|
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 |
inderpreet singh walia |
Indraprastha Apollo Hospital |
Ot Complex 1 ,First Floor , Indraprastha Apollo Hospital South DELHI |
9876624523
inderpreet.inderwalia@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Indraprastha Apollo Hospital Institutional Ethics Committee |
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 |
Dexmedetomidine |
dose - 0.5mcg/kg intravenous bolus , followed by 0.5mcg/kg/hour till the start of skin closure |
Comparator Agent |
placebo |
equal dose as compared to dexmedetomidine group intravenously |
|
Inclusion Criteria
|
Age From |
60.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
Patients with American Society of Anesthesiologists (ASA) physical status I-III aged 60- 80 years old, undergoing elective lumbar spine surgery |
|
ExclusionCriteria |
Details |
1. Patients age less than 60 years and more than 80 years old.
2. Patients with a pre-operative or intraoperative ECG (electrocardiogram) that showed severe bradycardia (sinus rhythm, heart rate less than 50/ min) or conduction block
3. Patients with associated renal, hepatic and respiratory dysfunction.
4. Patients with history of central nervous system disease such as head injury, stroke, previous neurosurgery, behavioral disturbances or mental retardation.
5. Patients with preoperative cognitive dysfunction (MMSE<24)
6. Patients on β-blockers, cimetidine, digoxin, α2-agonists, anticonvulsants or psychotropic medications
7. Patients with allergy to dexmedetomidine or another alpha-2 adrenergic receptor agonist
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Other |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1. Mini- Mental State Examination (MMSE) Scores.
2. 15-item quality of recovery score (QoR15) questionnaire.
|
1. Before Anaesthesia
2. Day 1 of Surgery
3. Day 2 of Surgery
4. Day 3 of Surgery
|
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Intraoperative propofol consumption.
2. Intraoperative and postoperative fentanyl requirement.
3. Haemodynamic changes
|
till the duration of surgery |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
24/06/2020 |
Date of Study Completion (India) |
14/08/2021 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
14/08/2021 |
Estimated Duration of Trial
|
Years="0" Months="4" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
yet to get published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is aimed to see the ’’ Effect of Intraoperative Dexmedetomidine infusion on Postopearative Cognitive Dysfunction and Recovery Quality in an Elderly Patient posted for Spine Surgery’’ Primary Outcome Variables: We will assess postoperative cognitive function and quality of recovery utilizing 1. 1. Mini- Mental State Examination (MMSE) Scores. 2. 2. 15-item quality of recovery score (QoR15) questionnaire. Secondary Outcome Variables: 1. Intraoperative propofol consumption. 2. Intraoperative and postoperative fentanyl requirement. 3. Haemodynamic changes. On the day of surgery, a baseline neurophysiological testing, using both MMSE (T0) and QoR15 (Q0) scoring would be done at 7:00 am. No sedative premedication will be prescribed. After adequate fasting, the patient will be shifted to the operating theatre where monitors such as electrocardiogram, pulse oximeter, and non-invasive blood pressure cuff will be applied and intravenous (IV) access secured. At this time computer generated randomization table will be used to assign each patient to either the dexmedetomidine group (Group D, n=30) or placebo group (Group P, n=30). A 50 ml syringe containing dexmedetomidine 4mcg/ml in normal saline for Group D or normal saline for Group P will be prepared shortly before induction anaesthesia by an anesthesiologist, who will be the part of study but not involved in the perioperative management of these patients. The study drug infusion will be started by the same anesthesiologist soon after the securing the IV access. Group D will receive IV dexmedetomidine at the rate of 0.5 mcg/kg/hr until beginning of skin closure. Group P will receive volume matched saline. |