| CTRI Number |
CTRI/2019/01/017108 [Registered on: 16/01/2019] Trial Registered Prospectively |
| Last Modified On: |
11/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of administration of the sedative drug, dexmedetomidine, on the pattern of recovery, in patients undergoing neurosurgery under general anesthesia |
|
Scientific Title of Study
|
Effect of intraoperative low dose dexmedetomidine on recovery profiles of sevoflurane and isoflurane based anesthesia for neurosurgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Unnikrishnan P |
| Designation |
Assistant Professor, Department of Anesthesia |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology , Trivandrum |
| Address |
Department of Anesthesia
Sree Chitra Tirunal Institute for Medical Sciences and Technology , Trivandrum
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447662321 |
| Fax |
|
| Email |
drunnikrishnanp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Unnikrishnan P |
| Designation |
Assistant Professor, Department of Anesthesia |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology , Trivandrum |
| Address |
Department of Anesthesia
Sree Chitra Tirunal Institute for Medical Sciences and Technology , Trivandrum
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447662321 |
| Fax |
|
| Email |
drunnikrishnanp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Unnikrishnan P |
| Designation |
Assistant Professor, Department of Anesthesia |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology , Trivandrum |
| Address |
Department of Anesthesia
Sree Chitra Tirunal Institute for Medical Sciences and Technology , Trivandrum
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447662321 |
| Fax |
|
| Email |
drunnikrishnanp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum |
|
|
Primary Sponsor
|
| Name |
Dr Unnikrishnan P |
| Address |
Dr Unnikrishnan P
Assistant Professor
Neuroanesthesia Division
Department of Anesthesia
Sree Chitra Tirunal Institute for Medical Sciences and Technology , Trivandrum |
| 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 |
| Unnikrishnan P |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
Neurosurgery Operation Theatre, Hospital Wing, 4th Floor, C Block
Thiruvananthapuram
KERALA |
9447662321
drunnikrishnanp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Sree Chitra Tirunal Institute for Medical Sciences and Technology, Institutional Ethical Committee(ECR/189/Inst/KL/2013) |
Approved |
| Sree Chitra Tirunal Institute for Medical Sciences and Technology, Institutional Ethical Committee(ECR/189/Inst/KL/2013) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (2) ICD-10 Condition: D332||Benign neoplasm of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group I patients will be given titrated Isoflurane |
Isoflurane 0.8-2% through inhalational route via an endotracheal tube, continuously, titrated to maintain Bispectral Index between 45-55. For the entire duration of the surgery, this will be continued, without interruption. Surgical duration may vary from 6-8 hours. |
| Intervention |
Group ID patients will be given Dexmedetomedine along with titrated Isoflurane |
Inj Dexmedetomedine 0.2 mcg/kg/hour as continuous intravenous infusion and Isoflurane 0.8-2% through inhalational route via an endotracheal tube, continuously, titrated to maintain Bispectral Index between 45-55. For the entire duration of the surgery, these two agents will be continued, without interruption. Surgical duration may vary from 6-8 hours. |
| Comparator Agent |
Group S patients will be given titrated Sevoflurane |
Sevoflurane 1-3% through inhalational route via an endotracheal tube, continuously, titrated to maintain Bispectral Index between 45-55. For the entire duration of the surgery, this will be continued, without interruption. Surgical duration may vary from 6-8 hours. |
| Intervention |
Group SD patients will be given Dexmedetomedine along with titrated Sevoflurane |
Inj Dexmedetomedine 0.2 mcg/kg/hour as continuous intravenous infusion and Sevoflurane 1-3% through inhalational route via an endotracheal tube, continuously, titrated to maintain Bispectral Index between 45-55. For the entire duration of the surgery, these two agents will be continued, without interruption. Surgical duration may vary from 6-8 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients categorized as American society of Anesthesiology (ASA) class 1 and 2.
Age 18-40 years.
Glasgow coma scale 15.
Patients undergoing surgeries with predicted duration >4 hours, for supratentorial lesions
|
|
| ExclusionCriteria |
| Details |
Patient refusal
American society of Anesthesiology (ASA) class III and above
Age less than 18 years and more than 40 years
Emergency surgery
Presence of intracranial vascular abnormalities ( Aneurysm, Arterio venous malformation)
Known allergy to Dexmedetomidine or any α2 agonists
Preoperative heart rate <50 bpm, Presence of Heart block
Antihypertensive medication with α-methyldopa or Clonidine
Patient on beta blockers
Presence of Coronary artery disease, Left ventricular dysfunction
Pregnant or Nursing woman
Participation in another drug study during the preceding 1 month period |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the recovery profile of patients receiving low dose dexmedetomidine along with volatile anesthetics |
Time taken (1) to open eyes (2) to obey verbal commands (3) to pass extubation criteria and (4) to get oriented to place and time once maintenance anesthetics are discontinued; RASS and VAS scores at extubation, 30, 60, 90 and 120 minutes after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters during the intraoperative period |
Every 10 minutes starting from induction; continued till the patient is shifted out of OR |
| Any pain, nausea or vomiting in the post extubation period |
Observed for the first 2 hours after extubation |
|
|
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)
|
04/02/2019 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective, randomized, double blinded, single center, case control study, comparing the recovery profile of 4 groups of patients (each consisting of 20) receiving anesthesia using any among Sevoflurane or Sevoflurane + Dexmedetomidine or Isoflurane or Isoflurane + Dexmedetomidine, based on time taken to attain various clinical endpoints during recovery and also by assessing the Richmond Agitation-Sedation Scale and Visual Analogue Scale scores at extubation, at 30 minutes, at 60 minutes, at 90 minutes and at 120 minutes after extubation (Primary outcome measure). As a secondary outcome measure, we will also be comparing the hemodynamic parameters in each group during the intraoperative period and also will be looking for the presence of any pain, nausea or vomiting during the first 2 hours following extubation. |