Comparing two drugs during monitoring of brain surgery patients

Comparison of dexmedetomidine versus fentanyl based anaesthetic protocols under patient state index guidance in patients undergoing elective neurosurgical procedures with intraoperative neurophysiological monitoring (IONM)- a randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026896

Enrollment

Registered

2020-07-29

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

None listed

Interventions

Intervention1: Dexmedetomidine infusion: Dexmedetomidine bolus 1 mcg/kg followed by 0.5 mcg/kg/hr in the intraoperative period Control Intervention1: Fentanyl infusion: Fentanyl infusion 2 mcg /kg bol

Eligibility

Inclusion criteria

Inclusion criteria: ASA Grade 1 and 2 GCS:- 14-15, Subjects posted for elective neurosurgical procedures with IONM

Exclusion criteria

Exclusion criteria: Pregnant or nursing mothers Subjects with history of allergy to any of the study medications Subjects with heart rate less than 60 per minute Surgical factors that hinders the placement of PSI sensor elctrodes Cardiac arrhythmias Subjects with hepatic, renal, cardiac dysfunction

Design outcomes

Primary

Measure	Time frame
Dexmedetomidine decreases the requirement of propofol intraoperatively without affecting the evoked potentials and hence can be used as an adjunct to propofol in total intravenous anaesthesia in neurosurgical proceduresTimepoint: The mean propofol consumed intraoperatively is assessed at the end of the surgery and the hourly consumption of propofol is also calculated	—

Secondary

Measure	Time frame
to assess the quality of intraoperative neurophysiological monitoring during neurosurgeryTimepoint: It depends on the number of times IONM stimulation done. it is recorded as per the surgical demand and the quality of recordings is assessed.	—

Countries

India

Contacts

Public ContactDr Jerry Jame Joy

Jawaharlal Institute of Post-Graduate Medical Education and Research

drprasannabidkar@gmail.com9442706168

Outcome results