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.

Comparison of the Quality of Recovery of patients undergoing elective Supratentorial craniotomy -Total Intravenous Anesthesia with propofol versus Balanced Anesthesia with Sevoflurane â?? A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027353

Enrollment

Registered

2020-08-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D3A0- Benign carcinoid tumors Health Condition 2: D330- Benign neoplasm of brain, supratentorial Health Condition 3: C715- Malignant neoplasm of cerebral ventricle Health Condition 4: C711- Malignant neoplasm of frontal lobe Health Condition 5: C714- Malignant neoplasm of occipital lobe Health Condition 6: C713- Malignant neoplasm of parietal lobe Health Condition 7: C712- Malignant neoplasm of temporal lobe

Interventions

Intervention1: 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

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18-65years 2.Supratentorial tumor with no significant clinical or radiological features of raised ICP and midline shift 3.ASA 1,2

Exclusion criteria

Exclusion criteria: 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 Preoperative Cognitive defects/Vision Loss, Symptomatic Raised Intracranial Pressure with hypertension and Bradycardia

Design outcomes

Primary

Measure	Time frame
1.Quality of Recovery as assessed by the QoR-40 QuestionnaireTimepoint: - To assess the quality of recovery using the QoR-40 scale on the Preoperative day 1 and 3 in neuro Ward or NICU.	—

Secondary

Measure	Time frame
1.Intraoperative Haemodynamic Profile. Timepoint: 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 RelaxationTimepoint: assessed intraoperative by the surgeon and graded as per the brain relaxation score.;3.Postoperative Recovery ProfileTimepoint: - 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 AnalgesiaTimepoint: -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.	—

Measure

Time frame

1.Intraoperative Haemodynamic Profile. Timepoint: 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 RelaxationTimepoint: assessed intraoperative by the surgeon and graded as per the brain relaxation score.;3.Postoperative Recovery ProfileTimepoint: - 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 AnalgesiaTimepoint: -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.

—

Countries

India

Contacts

Public ContactDr Georgene Singh

Christian Medical College

georgenesingh@gmail.com9443292504

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026