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CTRI Number  CTRI/2020/08/027353 [Registered on: 24/08/2020] Trial Registered Prospectively
Last Modified On: 22/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the quality of recovery for anaesthesia following surgery in patients with brain tumour with the intravenous anaesthesia and a combination of intravenous and gas.  
Scientific Title of Study   Comparison of the Quality of Recovery of patients undergoing elective Supratentorial craniotomy -Total Intravenous Anesthesia with propofol versus Balanced Anesthesia with Sevoflurane – A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Merlin Singh 
Designation  PG registrar 
Affiliation  CMC vellore 
Address  Department of Anesthesia , CMC hospital, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  07974857734  
Fax    
Email  merlinsingh94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Georgene Singh 
Designation  Professor , Head of Neuroanesthsia  
Affiliation  Christian Medical College 
Address  Department of Neuroanesthesia , Christian Medical College and Hospital , Vellore, Tamil Nadu 632002

Vellore
TAMIL NADU
632002
India 
Phone  9443292504  
Fax    
Email  georgenesingh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Georgene Singh 
Designation  Professor , Head of Neuroanesthsia  
Affiliation  Christian Medical College 
Address  Department of Neuroanesthesia , Christian Medical College and Hospital , Vellore, Tamil Nadu 632002

Cuddalore
TAMIL NADU
632002
India 
Phone  9443292504  
Fax    
Email  georgenesingh@gmail.com  
 
Source of Monetary or Material Support  
Ethics Committee Silver, Office of Research, I floor, Carman Block, Christian Medical College, Vellore, Tamil Nadu 632002. 
 
Primary Sponsor  
Name  Institutional Review Board 
Address  Ethics Committee Silver, Office of Research, 1 Floor , Carman block, Christian Medical College, Vellore, Tamil Nadu 632002 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Merlin Singh  Christian medical college and Hospital, Vellore  Neuro Operation rooms, Neuro Intensive care, Neurosurgery wards , Neuro High Dependency unit .
Vellore
TAMIL NADU 
07974857734

merlinsingh94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D3A0||Benign carcinoid tumors, (2) ICD-10 Condition: D330||Benign neoplasm of brain, supratentorial, (3) ICD-10 Condition: C715||Malignant neoplasm of cerebral ventricle, (4) ICD-10 Condition: C711||Malignant neoplasm of frontal lobe, (5) ICD-10 Condition: C714||Malignant neoplasm of occipital lobe, (6) ICD-10 Condition: C713||Malignant neoplasm of parietal lobe, (7) ICD-10 Condition: C712||Malignant neoplasm of temporal lobe,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Balanced Anesthesia   Induction:Inj Lignocaine 1.5 mg/kg iv, Inj Fentanyl 2-3 mcg/kg iv,Inj Propofol 1.5- 2 mg/kg iv until loss of consciousness and paralyzed with Inj Vecuronium 0.15 mg/kg iv. Maintenance Of Anaesthesia : Oxygen: Air (50%) at flows of 1.0L with Sevoflurane at a Minimum Alveolar Concentartion of 0.5 along with an infusion of Inj Propofol 100 mcg/kg/hr iv,IV infusion Vecuronium (0.0008-0.0012 mg/kg/min iv titrated to 2 twitches in Train Of Four in neuromuscular monitoring ) and IV Infusion Fentanyl (1-2 mcg/kg/hr iv)titrated to a Bispectral index of 40-60. 
Comparator Agent  TIVA   Induction:Inj Lignocaine 1.5 mg/kg iv,Inj Fentanyl 2 mcg/kg iv, Inj Propofol 1.5- 2 mg/kg iv until loss of consciousness and paralyzed with Inj Vecuronium 0.15 mg/kg iv. Maintenance of Anaesthesia: Oxygen: Air (50%) at flows of 1.0L and will receive an infusion of iv infusion Propofol 200-250 mcg/kg/hr, iv infusion Fentanyl 1-2 mcg/kg/hr, titrated to a Bispectral index of 40-60 without volatile anesthetic. Neuromuscular Blockade will be provided with inj Vecuronium infusion (0.0008-0.0012 mg/kg/min) titrated to 2 twitches in Train of Four in neuromuscular monitoring.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Age 18-65years
2.Supratentorial tumor with no significant clinical or radiological features of raised ICP and midline shift <1 cm.
3.ASA 1,2
 
 
ExclusionCriteria 
Details  1.Emergency Procedure
2.Severe cardiovascular or respiratory disease (ASA grade ≥3),
3.Pregnancy
4.Allergies to Propofol
5.History of Renal, Liver disease
6.Psychiatric illnesses
7.Patient refusal
8.Awake Craniotomy
9.GCS<15,
Preoperative Cognitive defects/Vision Loss,
Symptomatic Raised Intracranial Pressure with hypertension and Bradycardia
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Quality of Recovery as assessed by the QoR-40 Questionnaire  - To assess the quality of recovery using the QoR-40 scale on the Preoperative day 1 and 3 in neuro Ward or NICU. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Intraoperative Haemodynamic Profile.
 
HR & MAP will be recorded every 15 minutes from the baseline throughout the surgery, at the time of discontinuation (D/C) of IV or volatile agent (VA), at the time of emergence, extubation and 10 minutes after extubation.
The no of episodes of hypotension, hypertension, tachycardia, and bradycardia are recorded. The need for rescue drugs will be recorded.
 
2.Brain Relaxation   assessed intraoperative by the surgeon and graded as per the brain relaxation score. 
3.Postoperative Recovery Profile  - Emergence time, Extubation time , skin incision to skin closure time , time from induction to time of discontinuation of anesthetics will be recorded.
-Smoothness of extubation noted.
-Blood loss and the number of crystalloids, colloids and blood loss and blood products used will be noted.
-Modified Aldretes score will be recorded every 10 min in recovery.
-Time to discharge readiness will be recorded. 
4.Postoperative Analgesia  -VAS will be recorded at, 30 min, 1 h, 2, 4, 6, 12, 18, 24,48,72 h post-surgery.
-Time to the first requirement of analgesia is noted.
-A total dose of analgesics (opioids and others) will be recorded.
-Any postoperative events like nausea, vomiting, shivering, hypertension or hypotension or respiratory distress will also be recorded.
-Other neurosurgical events such as the development of hematoma, hydrocephalus, seizures, new onset focal neurological deficit will also be observed. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "93"
Final Enrollment numbers achieved (India)="93" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   25/08/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
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  

Craniotomies have a higher rate of postoperative complications than the general surgical population and adversely affects the quality of life. Moreover, patients undergoing craniotomy develop postoperative cognitive and physical deficits which makes it difficult to assess the postoperative quality of recovery.

With the advances in imaging and surgical techniques, the focus has shifted from merely eliminating pathology to ensuring maximal functional recovery as early as possible. Hence anesthetic techniques in addition to providing favorable intraoperative hemodynamics and brain relaxation must ensure a good quality of recovery to the patient as perceived by the patient.

Quality of recovery - 40 is one of the tools which helps us assess the quality of recovery postoperatively. QoR-40 questionnaire probes into 5 different aspects of health: physical comfort, physical independence, emotional state, psychological support, and pain. The validity, reliability, ease of use, and responsiveness of the QoR-40 have been confirmed in the neurosurgical population in previous studies.

                  In the practice of neuroanaesthesia, intravenous anesthesia with propofol and remifentanil has been preferred to inhalational anesthesia in terms of brain relaxation specifically in patients with raised intracranial pressure as it is known to lower subdural intracranial pressure,  provide higher cerebral perfusion pressure, and less pronounced cerebral swelling.

However, a comparison between intravenous and inhalational anesthesia for supratentorial craniotomy reveals that despite minimal differences, the short-term outcome in terms of hemodynamic stability and intraoperative brain relaxation is not affected in patients with normal intracranial pressure and both techniques are widely in use.

                  Citerio et al in their recent multicenter, randomized trial evaluating the equivalence of inhalational and intravenous anesthetic agents during craniotomy showed that the nearly postoperative recovery, intraoperative hemodynamics, brain relaxation were similar in the 2 groups and both techniques are acceptable for craniotomies.

                      Studies done in the general surgical population have demonstrated that TIVA with propofol provides a better quality of recovery as compared to Balanced General anesthesia.  However, there are no studies that have compared the quality of recovery with the 2 anesthetic techniques in the neurosurgical population.

                   We hypothesize that Balanced General Anaesthesia with Sevoflurane provides similar postoperative quality of recovery as compared to the use of TIVA with propofol and Fentanyl in patients undergoing supratentorial on the 1 st and 3 rd postoperative day (assessed by the QoR-40 questionnaire) in patients with tumors presenting for elective supratentorial craniotomy.


 
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