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Patients Undergoing Robotic SurgeryNCT03659539

Quality of Recovery After Robotic Surgery

A study testing PROPOFOL and Desflurane in people with Patients Undergoing Robotic Surgery, run by Nitin Sethi, DNB at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Patients Undergoing Robotic Surgery
What is being tested?
PROPOFOL and Desflurane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteIndia
Study dates
6 Sep 2018to 6 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

India1 site
  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060

Other trials in India

About this study

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

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.

Read the 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.

Being tested
PROPOFOL, Desflurane
Keywords
propofol, desflurane, robotic, recovery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PROPOFOLDrug

    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.

  • DesfluraneDrug

    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.

Study groups in NCT03659539
Study groupRoleWhat they receive
CLADS groupActive comparatorAnesthesia 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.
Receives: Drug: PROPOFOL
Desflurane groupActive comparatorAnesthesia 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
Receives: Drug: Desflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality-of-recovery

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

    Measured: From one day before surgery till postoperative day two

Secondary outcomes (9)
  1. 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

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

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

    Comparison of intra-operative heart rate between both the arms will be done

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

  3. 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

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

  4. Early recovery

    Time taken by the patient to open his/her eyes after discontinuation of anaesthesia will be noted

    Measured: From end of anaesthesia till 20-minutes postoperatively

  5. Early recovery

    Time taken for tracheal extubation after discontinuation of anaesthesia will be noted

    Measured: From end of anaesthesia till 20-minutes postoperatively

  6. 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)

    Measured: From end of anaesthesia till 24-hours postoperatively

  7. 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)

    Measured: From end of anaesthesia till 24-hours postoperatively

  8. 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).

    Measured: From end of anaesthesia till 24-hours postoperatively

  9. Intra-operative awareness

    Will be assessed using modified brice questionnaire. It consists of 5 questions pertaining to assessment of intraoperative awareness.

    Measured: From the end of anaesthesia till 48-hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2018
  2. Study start6 Sep 2018
  3. Primary completion6 May 2023
  4. Study completion6 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03659539
Sponsor's protocol ID
EC/08/18/1393
Status last verified
May 2023
First submitted
2 Sep 2018
Last updated
31 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PROPOFOL and Desflurane in people with Patients Undergoing Robotic Surgery, run by Nitin Sethi, DNB at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality-of-recovery (time frame: From one day before surgery till postoperative day two). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.

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