Quality of Recovery After Robotic Surgery

Patients Undergoing Robotic Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03659539
• Other study ID #: EC/08/18/1393
• Status: Completed
• Phase: N/A
• Start date: September 6, 2018
• Est. completion date: May 6, 2023

Study information

• Verified date: May 2023
• Source: Sir Ganga Ram Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 6, 2023
• Est. primary completion date: May 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Patients Undergoing Robotic Surgery

Intervention

Drug:
• PROPOFOL
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.
• Desflurane
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.

Locations

Country	Name	City	State
India	Sir Ganga Ram Hospital	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Nitin Sethi, DNB

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality-of-recovery	Quality-of-recovery will be assessed using QoR-15 questionnaire	From one day before surgery till postoperative day two
Secondary	Anaesthesia depth consistency	Comparison of anaesthesia depth adequacy using Varvel criteria parameters: percentage of the anesthesia time during which the BIS remained +/- 10 of the target BIS (50), median performance error (MDPE), median absolute performance error (MDAPE), and global score	From beginning of anesthesia (0-hours, baseline) till 8 hours intraoperatively
Secondary	Changes in intra-operative heart rate (beats per minute)	Comparison of intra-operative heart rate between both the arms will be done	From beginning of anesthesia (0-hours, baseline) till 8 hours intraoperatively
Secondary	Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg)	Comparison of intra-operative blood pressure- systolic, diastolic, and mean between both the arms will be done	From beginning of anesthesia (0-hours, baseline) till 8 hours intraoperatively
Secondary	Early recovery	Time taken by the patient to open his/her eyes after discontinuation of anaesthesia will be noted	From end of anaesthesia till 20-minutes postoperatively
Secondary	Early recovery	Time taken for tracheal extubation after discontinuation of anaesthesia will be noted	From end of anaesthesia till 20-minutes postoperatively
Secondary	Postoperative Sedation	Will be assessed using Modified Observer's assessment of alertness/sedation scale (OASS). It is a 6 point scale from 0 (fully sedated) to 5 (fully awake)	From end of anaesthesia till 24-hours postoperatively
Secondary	Postoperative Nausea and Vomiting	Will be assessed using PONV Scale. It is a 3 point scale from 0 (no nausea & vomiting) to 2 (vomiting present)	From end of anaesthesia till 24-hours postoperatively
Secondary	Postoperative Analgeisa	Will be assessed using 10-point numeric rating scale (NRS). It is a 10 point scale from 0 (no pain) to 10 (maximum pain).	From end of anaesthesia till 24-hours postoperatively
Secondary	Intra-operative awareness	Will be assessed using modified brice questionnaire. It consists of 5 questions pertaining to assessment of intraoperative awareness.	From the end of anaesthesia till 48-hours postoperatively