FindTrial
Sign In

Sedation during surgeries under regional anaesthesia with Propofol

A study to ascertain the target concentration of Propofol to achieve bispectral index guided sedation for monitored anaesthesia care using target-controlled infusion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017641
Enrollment
107
Registered
2019-02-13
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: N219- Calculus of lower urinary tract, unspecified Health Condition 2: M259- Joint disorder, unspecified Health Condition 3: M169- Osteoarthritis of hip, unspecified Health Condition 4: M179- Osteoarthritis of knee, unspecified Health Condition 5: K469- Unspecified abdominal hernia without obstruction or gangrene

Interventions

Intervention1: Propofol infusion using target controlled infusion pump: Faster onset, easy titration and rapid recovery from sedation Control Intervention1: NIL: NIL

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients belonging to American Society of Anaesthesiologists physical status grade I and II, aged between 18 to 70 years, scheduled to undergo surgery under spinal/epidural anaesthesia with an expected duration of 1-3 hrs.

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Hepatic insufficiency 3. Renal insufficiency 4. Pulmonary disease 5. History of chronic drug use that could affect the central nervous system 6. Significant hemodynamic instability 7. Known allergy to propofol 8. Pregnancy 9. Impaired hearing 10. Neurological deficits or a Glasgow Coma Scale score under 15 11. Known or predicted difficult airway 12. History of neurologic or psychiatric disorder

Design outcomes

Primary

MeasureTime frame
To determine target plasma concentration of propofol using Marsh model target controlled infusion pump for bispectral index guided sedation (60-80) during monitored anaesthesia care.Timepoint: 1-3 hours intra-operatively—

Secondary

MeasureTime frame
Any other side effectsTimepoint: 1-3 hours intra-operatively;Correlation of target plasma concentration of propofol with age and sexTimepoint: 1-3 hours intra-operatively;Recovery time after stopping infusionTimepoint: Every 1 minute Until patient attains OAA/S score of 5;Time to achieve BIS value between 80-60 after starting propofol infusionTimepoint: Every 1 minute till BIS value between 80-60;To assess correlation between BIS and Observerâ??s Assessment of Alertness/Sedation (OAA/S) scaleTimepoint: 1-3 hours intra-operatively;To calculate total dose of propofol consumed intraoperativelyTimepoint: 1-3 hours intra-operatively—

Countries

India

Contacts

Public ContactDr Deepak Chhabra

All India Institute of Medical Sciences, Jodhpur

deepakchhabra117@gmail.com8146563563

Outcome results

None listed

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