Quality of Recovery After Robotic Surgery

NCT03659539 | Completed DMC

• 1 other identifier: EC/08/18/1393
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Robotic approach to laparoscopic surgery has greatly facilitated undertaking complex surgery inside the abdominal cavity with ease. Robotic surgery is performed under general anaesthesia (GA), which is commonly administered either via the inhalational route or intravenous route. Currently, there is paucity of evidence regarding comprehensive patient outcome following robotic transabdominal surgery. The limited data that is available is restricted to specific outcome parameters such as hemodynamic profile, recovery times, and concomitant effects (post-operative nausea vomiting, pain). QoR (quality of recovery)-15 is a patient self- reported measurement of outcome to assess postoperative QoR. QoR-15 is a15-item questionnaire that assess physical and mental well-being of the patient after anesthesia and surgery. It is the first validated outcome assessment scale that has been evaluated using the Consensus-based Standards for the Selection of health Measurements Instruments (COSMIN) and fulfils the requirements for assessing QoR postoperatively. We plan to conduct this randomized controlled-trial to evaluate postoperative QoR using the QoR-15 questionnaire in patients undergoing robotic abdominal surgery under GA administered by routine techniques, namely, closed-loop anesthesia delivery system (CLADS) controlled total intravenous anesthesia (TIVA) with propofol or inhalation anesthesia with desflurane.

Conditions

Patients Undergoing Robotic Surgery

Keywords

propofol; desflurane; robotic; recovery

Outcome Measures

Primary Outcomes (1)

• Quality-of-recovery

  Quality-of-recovery will be assessed using QoR-15 questionnaire

  From one day before surgery till postoperative day two

Secondary Outcomes (9)

• Anaesthesia depth consistency

  From beginning of anesthesia (0-hours, baseline) till 8 hours intraoperatively

• Changes in intra-operative heart rate (beats per minute)

  From beginning of anesthesia (0-hours, baseline) till 8 hours intraoperatively

• Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg)

  From beginning of anesthesia (0-hours, baseline) till 8 hours intraoperatively

• Early recovery

  From end of anaesthesia till 20-minutes postoperatively

• Early recovery

  From end of anaesthesia till 20-minutes postoperatively

Study Arms (2)

CLADS group

ACTIVE COMPARATOR

Anesthesia will be induced with propofol administered using automated closed loop anesthesia delivery system (CLADS) which will be set to deliver Propofol. A BIS-value of 50 will be used as the target for induction of anesthesia. Thereafter anesthesia maintenance will be done with propofol, with its administration controlled with CLADS tuned to consistent anesthetic depth (BIS-50) feedback from the patients.

Drug: PROPOFOL

Desflurane group

ACTIVE COMPARATOR

Anesthesia will be induced with propofol administered using automated closed loop anesthesia delivery system (CLADS) which will be set to deliver Propofol. A BIS-value of 50 will be used as the target for induction of anesthesia. Thereafter anesthesia maintenance will be done with desflurane using an agent specific vaporiser, whose dial concentration will be adjusted to maintain a BIS of 50-55 in all the patients

Drug: Desflurane

Interventions

PROPOFOL DRUG

Propofol delivery will be controlled using automated closed loop anaesthesia delivery system which will control propofol delivery rate to consistent anaesthetic depth (BIS-50) feedback from the patient.

CLADS group

Desflurane DRUG

Desflurane delivery will be controlled using a agent specific vaporiser. The dial concentration of the vaporiser will be adjusted to maintain a BIS of 50-55 in the patients.

Desflurane group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I/II
• Undergoing elective robotic surgery of more than 60-minutes duration

You may not qualify if:

• Uncompensated cardiovascular illness (uncontrolled hypertension, atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced left ventricular compliance and diastolic dysfunction)
• Pre-existent neurological issues (previous neurosurgical intervention, psychiatric disease, morbid autonomic nervous system: orthostatic hypotension, transient ischemic attacks, history of alcohol/substance abuse, among others)
• Hepato-renal insufficiency
• Endocrinology problems, e.g. uncontrolled diabetes mellitus, hypothyroidism
• Known allergy/hypersensitivity to the study drugs (propofol, desflurane)
• Pulmonary dysfunction (chronic restrictive /obstructive lung disease, chronic smokers)
• Nutritional ailments: obesity (BMI \> 30 kg/m2), malnutrition (severe anaemia \[Hb \< 8gm%\] , hypoalbuminemia \[\< 3.5gm%\], bed-ridden moribund status)

Sponsors & Collaborators

• Nitin Sethi, DNB: lead

Study Sites (1)

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

MeSH Terms

Interventions

Propofol; Desflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Nitin Sethi, DNB

  Sir Ganga Ram Hospital, New Delhi, INDIA

  PRINCIPAL INVESTIGATOR

• Amitabh Dutta, MD

  Sir Ganga Ram Hospital, New Delhi, INDIA

  PRINCIPAL INVESTIGATOR

• Jayashree Sood, MD, FFRCA

  Sir Ganga Ram Hospital, New Delhi, INDIA

  STUDY CHAIR

• Goverdhan D Puri, MD, PhD

  Post Graduate Institute of Medical Education & Research, Chandigarh, India

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The attending anaesthesiologist will not be blinded to the technique utilized to administer GA and also to the in-OR recovery profile immediately after tracheal extubation. However, they will be blinded to postoperative recovery parameters, which will be noted by an independent assessor unaware of the technique utilized for administering GA.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor & Consultant

Model Details: 120-patients aged 18-65 years, ASA physical status I/II, of either sex, and undergoing elective major robotic surgery will be randomly allocated to one of the following two groups: Group-1 \[CLADS Group, n=60\]: Anaesthesia will be induced and maintained with propofol administered using the BIS feedback-based automated CLADS. Group-2 \[Desflurane Group, n=60\]: Anaesthesia will be induced with propofol CLADS and will be maintained intraoperatively by Desflurane titrated to BIS monitoring.

Study Record Dates

• First Submitted: September 2, 2018
• First Posted: September 6, 2018
• Study Start: September 6, 2018
• Primary Completion: May 6, 2023
• Study Completion: May 6, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)