Clinical trial NCT03659539: Quality of Recovery After Robotic Surgery
Official title: Evaluation of Quality of Recovery With QoR-15 Score Following Closed-Loop Anaesthesia Delivery System Guided Propofol Versus Desflurane General Anaesthesia in Patients Undergoing Transabdominal Robotic Surgery: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Undergoing Robotic Surgery
Keywords: propofol
desflurane
robotic
recovery
Lead sponsor: Sir Ganga Ram Hospital
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: The advent of robotic approach to laparoscopic surgery has transformed the practice of transabdominal procedures, especially those involving the pelvic region, such as, prostatectomy, hysterectomy, among others. In-line with the advantages of robotic intervention (greater access and precision), the type of patients who can undergo this surgery has also evolved. Whereas, morbidly obese patients, who were not amenable to 'open' or even 'laparoscopic' approach because of technical difficulties of gaining access to the operative organ/area; can now safely undergo surgery because of high-fidelity and intuitive robotic instrumentation. However, the robotic technique has its own share of concerns: first, it is difficult for the anesthesiologists to access the patient once the robotic arms are docked in position; and second, the extreme positioning (steep Trendelenberg, anti-Trendelenberg position) required to successfully apply the technique may lead to undue burden/adversity on patient's cardiovascular (tachycardia, hypertension, hypotension), respiratory (decreased lung compliance), and central nervous (elevated intracranial pressures) systems.

Therefore, general anesthesia (GA) techniques employed for robotic surgery should be robust and consistent. The common GA techniques, i.e. inhalational or a total intravenous anesthesia (TIVA) can be used. Advantage of inhalation anesthesia is easy titration of the agent by finely calibrated dial concentration control. In addition, the commonly used inhalation anesthetics such as sevoflurane or desflurane rapidly achieve anesthetic brain concentration and the effect can be efficiently reversed quickly upon discontinuation at the end of surgery. TIVA with intravenous anesthetic like propofol is delivered by via simple or target-controlled infusion pumps. Emerging evidence supports the use of propofol TIVA for it may also proffer decreased incidence of postoperative nausea-and-vomiting, anti-inflammatory effect, and anti-neoplastic action.

The evidence on beneficial effect of prolonged robotic surgery on postoperative patient recovery are scanty, unstructured, and limited only to male patients undergoing radical prostatectomy. For the want of a comprehensive patient assessment protocol, the available outcome study has been able to focus on a limited number of parameters, including, changes in intraocular pressure and the incidence of PONV/postoperative pain. Therefore, for knowing the actual outcome effect of GA for robotic surgery, it is essential to analyze elaborate quality-of-recovery from anesthesia based on compendious patients experiences rather than concentrating on specific end-points (hemodynamic profile, recovery time, etc.).

Quality of recovery-15 (QoR-15), a comprehensive patient-reported measure of quality of post-anesthesia, is an abridged form of the expansive 40-item questionnaire (QoR-40) score. QoR-15 assesses both physical and mental well-being of the patient after surgery under GA and is easier to administer. QoR-15 is the first outcome assessment scale which has been evaluated and validated using the consensus-based standards for the selection of health measurements instruments (COSMIN) and fulfils the requirement for being an effective tool for assessment of postoperative recovery/outcome in clinical trials.

Since there is a paucity of evidence on comprehensive post-anesthesia outcome following major robotic procedures and the choice of GA techniques employed for such procedures are subject to random selection; we aim to undertake this randomized-controlled trial to assess postoperative QoR with QoR-15 questionnaire in patients receiving anesthesia either by propofol administration facilitated by automated closed-loop anesthesia delivery system (CLADS) or desflurane inhalation.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Quality-of-recovery
timeFrame: From one day before surgery till postoperative day two
Secondary outcomes:
measure: Anaesthesia depth consistency
timeFrame: From beginning of anesthesia (0-hours, baseline) till 8 hours intraoperatively
measure: Changes in intra-operative heart rate (beats per minute)
timeFrame: From beginning of anesthesia (0-hours, baseline) till 8 hours intraoperatively
measure: Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg)
timeFrame: From beginning of anesthesia (0-hours, baseline) till 8 hours intraoperatively
measure: Early recovery
timeFrame: From end of anaesthesia till 20-minutes postoperatively
measure: Early recovery
timeFrame: From end of anaesthesia till 20-minutes postoperatively
measure: Postoperative Sedation
timeFrame: From end of anaesthesia till 24-hours postoperatively
measure: Postoperative Nausea and Vomiting
timeFrame: From end of anaesthesia till 24-hours postoperatively
measure: Postoperative Analgeisa
timeFrame: From end of anaesthesia till 24-hours postoperatively
measure: Intra-operative awareness
timeFrame: From the end of anaesthesia till 48-hours postoperatively
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
Study officials:
affiliation: Sir Ganga Ram Hospital, New Delhi, INDIA
name: Nitin Sethi, DNB
role: PRINCIPAL_INVESTIGATOR
affiliation: Sir Ganga Ram Hospital, New Delhi, INDIA
name: Amitabh Dutta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sir Ganga Ram Hospital, New Delhi, INDIA
name: Jayashree Sood, MD, FFRCA
role: STUDY_CHAIR
affiliation: Post Graduate Institute of Medical Education & Research, Chandigarh, India
name: Goverdhan D Puri, MD, PhD
role: STUDY_DIRECTOR
References: