Sedation during surgeries under regional anaesthesia with Propofol
Not Applicable
- Conditions
- Health Condition 1: N219- Calculus of lower urinary tract, unspecifiedHealth Condition 2: M259- Joint disorder, unspecifiedHealth Condition 3: M169- Osteoarthritis of hip, unspecifiedHealth Condition 4: M179- Osteoarthritis of knee, unspecifiedHealth Condition 5: K469- Unspecified abdominal hernia without obstruction or gangrene
- Registration Number
- CTRI/2019/02/017641
- Lead Sponsor
- A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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