A Study Comparing Two Methods of Giving Intravenous Anaesthesia and Their Effect on Recovery and haemodynamics in Patients Undergoing Cervical Spine Surgery.

Prospective randomised controlled study to compare the rate of recovery profile and haemodynamic profile using TCI propofol effect site vs plasma site (Eleveld plus opioid model) in anterior cervical discectomy and fusion surgery in tertiary care hospital. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112975

Enrollment

Registered

2026-06-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: M500- Cervical disc disorder with myelopathy

Interventions

Intervention1: TCI Propofol Effect Site Model (Eleveld + Opioid): Propofol will be administered using Target Controlled Infusion (TCI) pump with Eleveld plus opioid pharmacokinetic model targeting eff

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age : 18 to 65years 2.ASA : I, II, III 3.Patients undergoing elective Anterior Cervical discectomy and Fusion Surgery. 4.BMI 18kg/m2 to 35kg/m2 5. Patient willing to give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients refusal to give consent. 2. Egg allergy 3. Pregnant female patient 4. Preopneurodeficit which hampers assessment of recovery

Design outcomes

Primary

Measure	Time frame
Recovery time (time to eye opening, response to verbal commands and extubation in minutes) after general anaesthesiaTimepoint: Time from discontinuation of propofol infusion to: Eye opening (minutes) Response to verbal commands (minutes) Extubation (minutes)	—

Secondary

Measure	Time frame
Intraoperative haemodynamic profile (heart rate and mean arterial pressure)Timepoint: Baseline, after induction, after intubation, every 15 minutes intraoperatively, and at extubation and 3,5,10 minutes after extubation;Total dose requirement of neuromuscular relaxants during surgery.Timepoint: From induction of anaesthesia until completion of surgery.;Time taken to achieve modified Aldrete score greater than 9.Timepoint: From extubation until attainment of modified Aldrete score greater than 9 in the recovery room.	—

Measure

Time frame

Intraoperative haemodynamic profile (heart rate and mean arterial pressure)Timepoint: Baseline, after induction, after intubation, every 15 minutes intraoperatively, and at extubation and 3,5,10 minutes after extubation;Total dose requirement of neuromuscular relaxants during surgery.Timepoint: From induction of anaesthesia until completion of surgery.;Time taken to achieve modified Aldrete score greater than 9.Timepoint: From extubation until attainment of modified Aldrete score greater than 9 in the recovery room.

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Countries

India

Contacts

Public ContactDr Bhupesh Damodhar Kapgate

Department of Anaesthesiology,Seth GSMC Medical College and KEM Hospital,Parel,Mumbai-400012

shrikanta_oak@yahoo.com9324134023

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026