Comparison of Hemodynamic and Intubation Responses to Propofol Induction using Schneider model TCI Versus Bolus Technique
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Manipal Hospital
- Enrollment
- 140
- Locations
- 1
Study Overview
Brief Summary
This is study is a prospective, randomized, parallel group, single-center trial comparing the hemodynamic and intubation responses to propofol induction using Schneider model Target controlled infusion (TCI) and propofol IV. Adult patients between age of 18 to 60years undergoing elective surgery under general anesthesia will be randomly allocated to one of the two induction techniques using computer generated randomization. Hemodynamic parameters like Heart rate (HR), Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and Mean-arterial pressure (MAP) will be measured 1 minute before induction to 10 minutes after induction (or before surgical incision whichever is earlier).A total sample size of 140 participants (70 in each group) will be enrolled. The primary outcome is to evaluate the incidence of postinduction hypotension with TCI and manual bolus induction with propofol and secondary outcome is to compare the hemodynamic changes (heart rate and blood pressure) during laryngoscopy and tracheal intubation between TCI and manual bolus induction with propofol. The expected study duration is 10 months from the date of first patient enrolment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA1 AND ASA2 2)Patients with BMI less than 35 3)Patients undergoing general anesthesia with endotracheal tube placement.
Exclusion Criteria
- •Patient refusal to participate in study 2)Patient allergic to propofol 3)ASA III or IV 4)Patients undergoing surgeries which do not need general anesthesia or placement of endotracheal tube.
Investigators
Dr H S Murthy
Manipal Hospital