A study to evaluate the effects of a drug (propofol) in patients undergoing brain surgery for brain tumors

Bi Spectral Index (BIS) guided evaluation of propofol as anaesthetic adjunct with isoflurane in patients undergoing craniotomy and excision for space occupying lesion , a randomised control trial double blinded study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/06/014411

Enrollment

Registered

2018-06-05

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: null- Patients ,18-60 years of age, of either sex with intracranial space occupying lesion of ASA Grade I or II.

Interventions

Intervention1: Propofol infusion @100 microgram per kilogram body weight per minute intravenously.: Patients in Group A will be given maintenance dose of propofol @100 microgram per kilogram body weig

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of ASA Grade I or II. 2.Patients undergoing craniotomy and excision for space occupying lesions. 3.Expected duration of surgery is around 4-5 hours. 4.Patients with GCS 12 or above.

Exclusion criteria

Exclusion criteria: 1.Patient not giving informed consent. 2.Hypersensitive to propofol. 3.Pregnancy, breastfeeding. 4.Children below 16 years. 5.Kidney or liver problems.

Design outcomes

Primary

Measure	Time frame
1.BIS guided optimum dose of propofol for infusion intraoperatively. 2.Haemodynamic stability of propofol infusion intraoperatively. 3.Effects of propofol measured as reduced requirement of opioids and isoflurane intraoperatively. 4.Level of postoperative sedation using Ramsay sedation score.Timepoint: 1.BIS guided optimum dose of propofol for infusion intraoperatively. 2.Haemodynamic stability of propofol infusion intraoperatively. 3.Effects of propofol measured as reduced requirement of opioids and isoflurane intraoperatively. 4.Level of postoperative sedation using Ramsay sedation score.	—

Measure

Time frame

1.BIS guided optimum dose of propofol for infusion intraoperatively. 2.Haemodynamic stability of propofol infusion intraoperatively. 3.Effects of propofol measured as reduced requirement of opioids and isoflurane intraoperatively. 4.Level of postoperative sedation using Ramsay sedation score.Timepoint: 1.BIS guided optimum dose of propofol for infusion intraoperatively. 2.Haemodynamic stability of propofol infusion intraoperatively. 3.Effects of propofol measured as reduced requirement of opioids and isoflurane intraoperatively. 4.Level of postoperative sedation using Ramsay sedation score.

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Secondary

Measure	Time frame
Any side effects intraoperatively.Timepoint: Any side effects intraoperatively.	—

Countries

India

Contacts

Public ContactDr Bhartesh Kumar Rai

King George Medical University,Lucknow,UP-226003

monica_kohli@rediffmail.com9839041228

Outcome results

None listed

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