Skip to content

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

A multicentric, prospective, observational Registry for assessment of clinical outcomes in Indian adult (more than 18 years of age), 18-50 and more than 65 years inpatients undergoing surgery more than 2 hrs duration during Suprane anaesthesia - RISE

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2013/07/003817
Enrollment
400
Registered
2013-07-18
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: null- anesthesia for inpatient surgery in adults

Interventions

Intervention1: Suprane: Inhalation via specific vaporiser designed for Suprane. MAC decreases with increasing age. Induction: 4-11% usually produces surgical anaesthesia in 2-4 minutes. Maintenance: W

Sponsors

Baxter India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (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

Exclusion criteria

Exclusion criteria: (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

Design outcomes

Primary

MeasureTime frame
Time to Recovery parameters- - Time to extubation (time from discontinuation of Desflurane to extubation) - Time to response to verbal command (time from discontinuation of desflurane until response to command [eg, â??squeeze fingerâ?? or â??open eyesâ??]) - Time to orientation (time from discontinuation of Desflurane to awareness of place, time, date) Timepoint: Baseline

Secondary

MeasureTime frame
Airway eventsTimepoint: Baseline;Average wake-up time of patients after general anesthesia with Desflurane stratified by body mass index [BMI] and age Timepoint: Baseline;Incidence and severity of Postoperative Nausea /Pain/Vomiting/shivering Timepoint: Baseline;PACU duration Timepoint: Baseline;Time taken from discontinuation of Desflurane to readiness for discharge from OT to PACU Timepoint: Baseline

Countries

India

Contacts

Public ContactSharad Jain

Baxter India Pvt Ltd

ashok_moharana@baxter.com4500200

Outcome results

None listed

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