| 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 |
|
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Source of Monetary or Material Support
|
| Ethics Committee Silver, Office of Research, I floor, Carman Block, Christian Medical College, Vellore, Tamil Nadu 632002. |
|
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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.
|
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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
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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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. |
|
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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. |