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Comparing two sedation drug combinations for improving comfort in patients undergoing awake brain and blood vessel procedures.

Comparison of remifentanil ketamine versus remifentanil propofol infusion for awake neuroendovascular procedures, a randomized controlled trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110339
Enrollment
50
Registered
2026-05-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: Q282- Arteriovenous malformation of cerebral vessels Health Condition 2: D320- Benign neoplasm of cerebral meninges Health Condition 3: I671- Cerebral aneurysm, nonruptured Health Condition 4: I607- Nontraumatic subarachnoid hemorrhage from unspecified intracranial artery Health Condition 5: Q283- Other malformations of cerebral vessels Health Condition 6: I678- Other specified cerebrovascular diseases

Interventions

Intervention1: Remifentanil and Ketamine: Remifentanil intravenous infusion at 0.02 to 0.05 microgram per kg per min and Ketamine infusion at 0.5 per kg per hour, titrated to maintain Bispectral Index

Sponsors

Postgraduate Institute of Medical Education and Research Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 to 65 years, ASA physical status I and II, GCS more than 14, patients posted for interventional neuroradiological procedures, willing to give written informed consent

Exclusion criteria

Exclusion criteria: Uncooperative patients, refusal of consent, ASA 3 and above, history of psychiatric disorder, frequent poorly controlled seizures, anticipated difficult airway, chronic cough, moderate to severe obstructive sleep apnea, chronic pain and opioid abuse, known allergy to propofol or remifentanil or ketamine

Design outcomes

Primary

MeasureTime frame
Patient comfort during conscious sedation using Modified Gloucester Comfort Score (MGCS) intraoperatively.Timepoint: At the end of procedure.—

Secondary

MeasureTime frame
Haemodynamic parameters (HR and MAP)Timepoint: Intraoperative;Consumption of rescue analgesic agent FentanylTimepoint: Intraoperative;Neuroradiologist satisfaction- Image quality and ease of procedureTimepoint: End of procedure;Total procedural durationTimepoint: End of procedure;Radiation exposure by Dose Area Product (DAP)Timepoint: End of procedure;Periprocedural complications- hemorrhagic and thromboembolicTimepoint: Intraoperative;Conversion to general anaesthesiaTimepoint: Intraoperative;Postoperative pain by NRS and PONVTimepoint: Recovery room;Neurological outcome by Modified Rankin ScaleTimepoint: At discharge—

Countries

India

Contacts

Public ContactDr Rajeev Chauhan

PGIMER Chandigarh

dr.rajeevchauhan@gmail.com7087422950

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026