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Assess the effect of two drugs( ketamine and dexmedetomidine) on cranial nerve monitoring during brain surgery

Evaluation of effect of addition of ketamine or dexmedetomidine along with propofol infusion on cranial nerve monitoring in patients undergoing posterior fossa surgery - a prospective randomized double-blind placebo- controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020817
Enrollment
42
Registered
2019-08-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: C717- Malignant neoplasm of brain stem

Interventions

Intervention1: Inj ketamine Infusion: Inj Ketamine Infusion intravenous at the dose of 0.25mg/kg/hr started immediately after induction and continued till Dural closure is started Intervention2: Inj D

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-60 years 2. ASA I-III 3. GCS 13 - 15 4. Patients undergoing elective neuro surgery for posterior fossa tumour, requiring intraoperative cranial nerve monitoring and having no evidence of raised ICP.

Exclusion criteria

Exclusion criteria: 1. Patients with features of raised ICP 2. Severe cardiovascular diseases (such as heart block, heart failure, left ventricular dysfunction) 3. Significant pulmonary, renal, hepatic or neuromuscular disease, 4. Pre-op involvement of cranial nerves except VIIth nerve 5. History of chronic alcohol use 6. Defined allergy to any of study drugs

Design outcomes

Primary

MeasureTime frame
1.To assess the effect of ketamine and dexmedetomidine infusion on amplitude of corticobulbar MEP of the cranial nerves 2.To assess the effect of ketamine and dexmedetomidine infusion on latency of corticobulbar MEP of the cranial nerves Timepoint: Baseline at induction, At 30 minutes, At 45 minutes, At 60 minutes, At start of tumour dissection, 15 minutes after starting tumour dissection, 30 minutes after starting tumour dissection, 45 minutes after starting tumour dissection, 60 minutes after starting tumour dissection, 75 minutes after starting tumour dissection, 90 minutes after starting tumour dissection, 105 minutes after starting tumour dissection, 120 minutes after starting tumour dissection, At haemostasis, End of procedure—

Secondary

MeasureTime frame
Effect on free running and triggered EMG’s of cranial nerves Effect on TcMEP of peripheral muscle groups Changes in perioperative hemodynamic parameters Dosage of propofol used Total opioid requirement in intraoperative period Use of any vasopressors for correction of hypotension Use of drugs for correction of hypertension Effect on brain relaxation Effect on extubation Duration of post-op mechanical ventilation Post-operative complications if any Timepoint: Baseline at induction, At 30 minutes, At 45 minutes, At 60 minutes, At start of tumour dissection, 15 minutes after starting tumour dissection, 30 minutes after starting tumour dissection, 45 minutes after starting tumour dissection, 60 minutes after starting tumour dissection, 75 minutes after starting tumour dissection, 90 minutes after starting tumour dissection, 105 minutes after starting tumour dissection, 120 minutes after starting tumour dissection, At haemostasis, End of procedure—

Countries

India

Contacts

Public ContactSharmishtha Pathak

All India Institute of Medical Sciences, Rishikesh

drpriyankagupta84@gmail.com9811894899

Outcome results

None listed

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