A Multicenter, Prospective, Observational Registry for assessment of clinical outcomes in Indian adult (more than 18 years of age), 18-50 and more than 65 years inpatient patients undergoing surgery for more than 2 hours duration during Suprane ® Anaesthesia
- Conditions
- Health Condition 1: null- anesthesia for inpatient surgery in adults
- Registration Number
- CTRI/2013/07/003817
- Lead Sponsor
- Baxter India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 400
(1)Male or female (non-pregnant, non-lactating) who is > 18 years of age, either 18-50 years or >65 years
(2)Are American Society of Anesthesiologists physical status of I, II, or III
(3)Scheduled to receive desflurane as the general anesthetic for a surgical procedure with an anticipated duration of 120 minutes or longer
(4)Expected to be transferred to the PACU after surgery or Planned extubation in operative room
(5)Has provided written informed consent (unless the responsible IRB/IEC has granted a waiver of the requirement for informed consent
(1)Age group 51-64 years of age. Known or suspected genetic susceptibility to malignant hyperthermia
(2)Patient in whom general anesthesia is contraindicated
(3)Known sensitivity to desflurane or to other halogenated agents
(4)Patients who are pregnant or lactating
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Recovery parameters- - Time to extubation (time from discontinuation of Desflurane to extubation) <br/ ><br>- Time to response to verbal command (time from discontinuation of desflurane until response to command [eg, â??squeeze fingerâ?? or â??open eyesâ??]) <br/ ><br>- Time to orientation (time from discontinuation of Desflurane to awareness of place, time, date) <br/ ><br>Timepoint: Baseline
- Secondary Outcome Measures
Name Time Method Airway eventsTimepoint: Baseline;Average wake-up time of patients after general anesthesia with Desflurane stratified by body mass index [BMI] and age <br/ ><br>Timepoint: Baseline;Incidence and severity of Postoperative Nausea /Pain/Vomiting/shivering <br/ ><br>Timepoint: Baseline;PACU duration <br/ ><br>Timepoint: Baseline;Time taken from discontinuation of Desflurane to readiness for discharge from OT to PACU <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: Baseline