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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03099616
Date of registration:	28/03/2017
Prospective Registration:	Yes
Primary sponsor:	Dr Nitin Sethi
Public title:	Automated Closed Loop Propofol Anaesthesia Versus Desflurane Inhalation Anaesthesia In Bariatric Surgery
Scientific title:	Automated Closed Loop Propofol Anaesthesia Versus Desflurane Inhalation Anaesthesia In Obese Patients Undergoing Bariatric Surgery: A Comparative Randomized Analysis of Recovery Profile
Date of first enrolment:	April 4, 2017
Target sample size:	40
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03099616
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Outcomes Assessor).
Phase:	Phase 4

Countries of recruitment
India

Contacts

Name:	Nitin Sethi, DNB
Address:
Telephone:
Email:
Affiliation:	Sir Ganga Ram Hospital, New Delhi, INDIA

Name:	Jayashree Sood, MD,FFRCA
Address:
Telephone:
Email:
Affiliation:	Sir Ganga Ram Hospital, New Delhi, INDIA

Name:	Amitabh Dutta, MD
Address:
Telephone:
Email:
Affiliation:	Sir Ganga Ram Hospital, New Delhi, INDIA

Name:	Goverdhan D Puri, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Post Graduate Institute of Medical Education & Research, Chandigarh, India

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients of age 18-65 years

- BMI > 35 kg/m2

- Either sex

- ASA physical status II & III

- Undergoing laparoscopic/ robotic bariatric surgery

Exclusion Criteria:

- Uncompensated cardiovascular disease (e.g. uncontrolled hypertension,
atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV
compliance, diastolic dysfunction)

- Hepato-renal insufficiency

- Uncontrolled endocrinology disease (e.g. diabetes mellitus, hypothyroidism)

- Known allergy/hypersensitivity to the study drug

- Pulmonary dysfunction (obstructive/restrictive lung disease)

- Acute/chronic drug dependence/substance abuse

- Requirement of postoperative ventilation

- Refusal to informed consent

Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Anesthesia; Bariatric Surgery

Intervention(s)

Drug: Desflurane

Drug: Propofol

Primary Outcome(s)

Intermediate recovery [Time Frame: From end of anaesthesia till 180-minutes postoperatively]

Early Recovery [Time Frame: From end of anaesthesia till 30-minutes postoperatively]

Early Recovery [Time Frame: From end of anaesthesia till 20-minutes postoperatively]

Secondary Outcome(s)

Changes in intra-operative heart rate (beats per minute) [Time Frame: From beginning of anesthesia (0-hours, baseline) till 6 hours intra-operatively]

Postoperative Analgeisa [Time Frame: From end of anaesthesia till 24-hours postoperatively]

Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg) [Time Frame: From beginning of anesthesia (0-hours, baseline) till 6 hours intraoperatively]

Patient Satisfaction [Time Frame: From end of anaesthesia till 24-hours postoperatively]

Postoperative Nausea and Vomiting [Time Frame: From end of anaesthesia till 24-hours postoperatively]

Postoperative Sedation [Time Frame: From end of anaesthesia till 24-hours postoperatively]

Anesthesia Depth Consistency [Time Frame: From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively]]

Secondary ID(s)

EC/01/17/1105

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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