Skip to main content
Clinical Trials/CTRI/2021/06/034393
CTRI/2021/06/034393Not yet recruitingPhase 4

"Comparison of psychomotor recovery in patients receiving either intravenous propofol or dexmedetomidine infusions as part of balanced general anaesthesia: A prospective randomized single-blind study"

Not provided1 site in 1 country70 target enrollmentStarted: January 7, 2021Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Enrollment
70
Locations
1
Primary Endpoint
compare the psychomotor recovery of patients receiving iv dexmedetomidine versus iv propofol infusion with Digit Symbol Substitution Test(DSST)[Annexure1] postoperatively

Study Overview

Brief Summary

Immediate post-operativerecovery forms a prerequisite for any successful anaesthetic procedure-especially so in day care surgeries.   The DSST, primarily measures visual recording andincludes a motor component. It is an useful indicator of changes in sensoryprocessing performance induced by psychoactive tests.

There are only a few studies comparingpsychomotor effects of dexmedetomidine and propofol. We hypothesise that a goodDSST score indicates a better recovery from anaesthesia which can translate toan early discharge from a limited bed available Post Anaesthesia Care Unit(PACU) to postoperative ward. Therefore, we would like to compare the abovedrugs using DSST as a measure of psychomotor recovery surgeries under generalanaesthesia

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Patients with American Society of Anaesthesiologists physical status I, II, III aged 18 to 65 years.
  • 2.Patients who are scheduled for surgeries under general anaesthesia.
  • 3.Minimum duration of surgery lasting more than 120 minutes.

Exclusion Criteria

  • 1.Patients unwilling to participate in the study.
  • 2.Patients who are unable to give informed consent.
  • 3.BMI>30kg/m
  • 4.Patients with known history of psychiatric illness, chronic drug or alcohol abuse.
  • 5.Patients with known hypersensitivity to drugs used.
  • 6.Pregnant and lactating women.
  • Patients on concurrent sedative medications.
  • 7.Patients who are unable to attempt or perform the DSST test.

Outcomes

Primary Outcomes

compare the psychomotor recovery of patients receiving iv dexmedetomidine versus iv propofol infusion with Digit Symbol Substitution Test(DSST)[Annexure1] postoperatively

Time Frame: 15 min, 30 min , 60 min , 90 min , 120 min

Secondary Outcomes

  • i.To note the number of additional bolus doses of fentanyl and propofol given intraoperatively.(ii.To note the total amount of propofol and fentanyl consumed intraoperatively.)

Investigators

Sponsor
Not provided

Study Sites (1)

Loading locations...

Similar Trials