| CTRI Number |
CTRI/2020/11/028784 [Registered on: 02/11/2020] Trial Registered Prospectively |
| Last Modified On: |
29/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Anesthesia for elderly patients undergoing brain tumor surgery without opioids. |
|
Scientific Title of Study
|
OPIoid sparing Anesthesia Technique for supratentorial craniotomy in geriatric patients [OPIATE]: a randomized open labelled study |
| Trial Acronym |
OPIATE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Indu Kapoor |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Department of Neuroanesthesiology and Critical Care AIIMS New Delhi ANSARI NAGAR, SOUTH DELHI New Delhi DELHI 110029 India |
| Phone |
09013439134 |
| Fax |
|
| Email |
dr.indu.me@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Indu Kapoor |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Department of Neuroanesthesiology and Critical Care AIIMS New Delhi ANSARI NAGAR, SOUTH DELHI South DELHI 110029 India |
| Phone |
09013439134 |
| Fax |
|
| Email |
dr.indu.me@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Indu Kapoor |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Department of Neuroanesthesiology and Critical Care AIIMS New Delhi ANSARI NAGAR, SOUTH DELHI South DELHI 110029 India |
| Phone |
09013439134 |
| Fax |
|
| Email |
dr.indu.me@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Department of Neuroanaesthesiology and Critical Care |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Indu Kapoor |
NEUROSCIENCE CENTER |
Department of Neuroanesthesiology and critical care AIIMS New Delhi South DELHI |
09013439134
dr.indu.me@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS 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 and scalp block |
Dexmedetomidine bolus @1mcg/kg over 10 mins before induction followed by 0.2-0.7 mcg/kg/hr. + Scalp block with ropivacaine [0.25%] after induction of anesthesia [Group DS] |
| Comparator Agent |
Opioids |
Fentanyl @ 1mcg/kg at induction followed by 1 mcg/kg/hr for maintenance [Group F] |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Written informed consent
2. American Society of Anesthesiologists class I&II
3. Age of >65 years
4. Either gender
5. Supratentorial brain tumor with tumor diameter of ≤ 40 mm
6. Full Glasgow coma score (E4V5M6)
7. Estimated operative time of ≤ 6 hours and anesthesia time of ≤ 8 hours
|
|
| ExclusionCriteria |
| Details |
1. Non consenting patient
2. Any history of previous brain surgery
3. Current or past history of any cardiac disease or medication
4. Any history of lung disease, liver or kidney dysfunction
5. Patients who had sensitivity to opioids, dexmedetomidine, ropivacaine
6. Body mass index of > 35 kg/m2
7. Preoperative cognitive dysfunction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Time to emergence
2.Postoperative immediate pain |
1.From discontinuation of anesthetics to eye opening on command in minutes
2. 10 minutes after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Extubation time |
1. From discontinuation of anesthetics to tracheal extubation in minutes |
| 2. Postoperative delirium |
2. Assessed using CAM-ICU 60 minutes after extubation |
| 3. Postoperative early cognitive dysfunction |
Assessed using MMSE 60 minutes after extubation] |
| 4. Postoperative side effects: nausea,vomiting, shivering, hemodynamic instability, respiratory depression |
Postoperative period[24 hrs] |
| 5. Other respiratory parameters (any subclinical respiratory depression): Ph, PaO2, PaCo2, Hco3, Lact, Sao2, Hb |
Postoperative period [24 hrs] |
| 6. Time for first rescue analgesic: |
Postoperative period [24 hrs] |
7. Length of ICU stay
|
. |
8. Length of Hospital stay
|
. |
9. Intraoperative brain relaxation [Cerebral relaxation score]
|
intraoperative period |
10. Intraoperative hemodynamic disturbances [hypotension, bradycardia]
|
intraoperative period |
11. Intraoperative fentanyl consumption
|
End of surgery |
|
|
Target Sample Size
|
Total Sample Size="22" Sample Size from India="22"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="22" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/11/2020 |
| Date of Study Completion (India) |
09/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Opioids have been an integral part of anesthesia practice and are not without side effects. Geriatric population have more pronounced opioid side effects during perioperative period which include, sedation, respiratory depression, shivering, nausea and vomiting, dizziness, constipation, pruritus and ileus. Specifically in geriatric patient undergoing neurosurgical procedures, increased sensitivity towards opioids, disturbed cerebral autoregulation in the postoperative period, coupled with opioid induced hypotension, respiratory depression and carbon dioxide retention leading to an undesirable rise in intracranial pressure and further sedation caused by these drugs may lead to a delayed emergence. In these patients time to emergence from anesthesia is important for rapid neurological examination. A depressed level of consciousness usually indicates residual anesthesia, most commonly due to an opioid overdose (bilaterally constricted pupils), but may be also be due to other causes, such as an intracranial hematoma, cerebral edema, nonconvulsive status epilepticus, hypoglycemia, electrolyte disturbances, hypothermia, pneumocephalus, vascular occlusion, and ischemia. Supratentorial tumors are the most common intracranial neoplasms in geriatric patients patients (>65 years). Important eloquent areas involved in speech, sensorimotor functions, white matter tracts and primary visual cortex, all are in supratentorial region. Resection of tumor that involve or are in close proximity to these areas are associated with a high risk of poor postoperative neurocognitive recovery, language dysfunction and motor weakness. While mild cognitive impairment and lethargy is not uncommon in geriatric patients in the immediate postoperative period, failure to awaken within 5- 10 minutes of cessation of anesthetic drugs should prompt a search for other potential causes of a delayed emergence. The practice of opioid sparing anesthesia [OSA] has the potential to innovate and transform the practice of neuroanesthesia and enhance the postoperative recovery profile, especially in geriatric patients. The OSA technique in the form of scalp block and combination of drugs such as dexmedetomidine, ketamine, lignocaine, magnesium etc can be used to preclude the use of opioids. With regard to postoperative recovery, presently there are no trials that have studied the effect of OSA in terms of time to emergence from cessation of anesthesia in geriatric patients undergoing supratentorial craniotomy surgery. The hypothesis of our study is that an OSA technique would be a better alternative to the conventional anesthetic technique using opioid throughout the surgery in geriatric neurosurgical patients undergoing craniotomy for supratentorial tumor surgery.
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