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Comparing Quality of Recovery Between Desflurane & Isoflurane in Eye Surgery Patients at Dr George Mukhari Acad Hospital (DIQoR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04188314
Recruitment Status : Completed
First Posted : December 5, 2019
Last Update Posted : October 18, 2022
Sponsor:
Information provided by (Responsible Party):
Dr. Charle Steyl, Sefako Makgatho Health Sciences University

Brief Summary:

Recovery after surgery and anaesthesia has traditionally been assessed with objective measures including time to awakening, time to regaining airway reflexes, duration of stay in the recovery room and/or hospital, and incidence of adverse events like pain and post-operative nausea and vomiting.

Increasingly, the patient's experience of their post-operative recovery is being recognised as an important outcome after surgery. The 15-Item Quality of Recovery score (QoR-15) has been validated to give a patient-centred global measure of overall health status after surgery and anaesthesia. This score has recently been translated and validated in isiZulu.

Desflurane is the newest anaesthetic vapour to market, with many benefits from the anaesthetist's perspective: faster time to awakening, faster time to regaining airway reflexes, and a clearer sensorium post-operatively. However, there is a paucity of data evaluating whether this translates to better quality of recovery for the patient. Desflurane is more expensive than other volatiles; for economic use, it is recommended to use Desflurane with a low flow (up to 2L) anaesthetic technique.

Isoflurane is the most commonly used volatile anaesthetic agent at Dr. George Mukhari Academic Hospital. Concerns about the increased cost of desflurane compared to isoflurane limits the use of this novel agent in the public sector in South Africa. Following an extensive literature review, no studies could be found comparing quality of recovery between desflurane and isoflurane using a validated quality of recovery tool like the QoR-15.

The research question in this study is whether there is a clinically significant difference in post-operative quality of recovery (using the QoR-15 score) between desflurane and isoflurane inhalational anaesthesia in adult patients presenting for elective ophthalmological surgery under general anaesthesia.

This study will therefore compare quality of recovery between desflurane and isoflurane inhalational anaesthesia. Furthermore, the study will evaluate the relative cost of using either volatile with a basal flow anaesthetic technique.


Condition or disease Intervention/treatment Phase
Quality of Recovery Anesthesia Recovery Period Drug: Desflurane Drug: Isoflurane Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will be conducted as a randomised, controlled, patient and observer blinded, single-centre trial with two parallel groups and a primary end-point of 15-point Quality of Recovery Score on day 1 after surgery. Randomization will be performed as block randomization with a 1:1 allocation.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

The patient will be blinded (masked) to the group they have been randomised to, as the vapour will only be started after induction of anaesthesia. The research assistant administering the post-operative QoR-15 will be blinded (masked) to the intervention.

The treating anaesthetist, the Chief Researcher and theatre staff will not be blinded to the intervention, as this would not be practical. All treating anaesthetists and theatre staff will be strongly inculcated not to disclose the allocation status of the participant at any time prior or after the general anaesthetic.

The piece of paper indicating the group will be attached to the Case Report Form. The Case Report Form will be collected by the Chief Researcher and will not be in the patient's file where it may unblind the patient or research assistant.

There are no circumstances under which unblinding will be permissible.

Primary Purpose: Supportive Care
Official Title: A Randomised Control Trial to Compare Quality of Recovery Between Desflurane and Isoflurane Inhalational Anaesthesia in Patients Receiving General Anaesthesia for Ophthalmological Surgery at Dr. George Mukhari Academic Hospital
Actual Study Start Date : February 20, 2020
Actual Primary Completion Date : February 22, 2022
Actual Study Completion Date : February 22, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Desflurane Interventional Group

The intervention group will receive desflurane for maintenance of anaesthesia. Standard protocols for induction and maintenance of anaesthesia will be followed, as discussed with Prof. F. Puehringer, an international expert in the field of desflurane use. A detailed leaflet describing the protocol has been developed, which will be handed to the treating anaesthetist on the day of surgery.

After induction of anaesthesia and after the airway is secured, fresh gas flow is reduced to 2 l/min and the desflurane vaporiser is opened to 12%. This is maintained until 1MAC is reached. The fresh gas flow will then be turned down to 0.2-0.5 l/min (taking into consideration the machine leak) and the vaporiser adjusted to maintain 1MAC. The use of basal to minimal fresh gas flow is intentional, to minimise the amount of anaesthetic vapour used. When basal flow is used, 100% oxygen is required to meet oxygen demand.

Drug: Desflurane
The intervention group will receive desflurane for maintenance of anaesthesia, and the quality of recovery score will be compared post-operatively with the control group who received isoflurane.
Other Name: Suprane

Active Comparator: Isoflurane Control Group
The control group will receive Isoflurane for maintenance of anesthesia. After induction of anaesthesia and after the airway is secured, fresh gas flow is reduced to 2 l/min and the Isoflurane vaporiser is opened and adjusted to attain 1MAC. Once 1MAC is attained, the fresh gas flow will be reduced to 0.2-0.5 l/min (taking into consideration the machine leak) and the vaporiser will be adjusted to maintain 1MAC. The use of basal to minimal fresh gas flow is intentional, to minimise the amount of anaesthetic vapour used. When basal flow is used, 100% oxygen is required to meet oxygen demand.
Drug: Isoflurane
The control group will receive Isoflurane for maintenance of anesthesia. The quality of recovery score will be compared post-operatively with patients in the intervention group who received desflurane.
Other Name: Forane




Primary Outcome Measures :
  1. Post-operative Quality of Recovery score, assessed by QoR-15, change from baseline QoR-15 score pre-operatively [ Time Frame: Pre-operative day 0 and Post-operative day 1 ]

    A baseline 15-Item Quality of Recovery score (QoR-15) will be measured pre-operatively, and a repeat will be done on Day 1 post-operatively.

    The QoR-15 is a 15-item score evaluating both physical and mental well-being by assessing five dimensions: emotional state, physical comfort, psychological support, physical independence and pain. Each of the 15 items are scored by the patient from 0 (worst score) to 10 (best score), giving a lowest possible score of 0 (worst outcome), and a highest possible score of 150 (best outcome). This continuous composite score allows comparisons between intervention groups. The minimal clinically important difference (MCID) and patient acceptable symptom state score for the QoR-15 score has been determined: the MCID is 8 and the acceptable symptom state score is 118.



Secondary Outcome Measures :
  1. Consumption of anaesthetic vapour with basal anaesthetic technique [ Time Frame: Intraoperative day 0 ]
    The vapour use per case in millilitres of isoflurane or desflurane will be recorded from the anaesthetic machine.

  2. Cost of anaesthetic vapour with basal to minimal flow anaesthetic technique [ Time Frame: Intraoperative day 0 ]
    Calculating cost of isoflurane and desflurane used based on consumption and cost data from hospital pharmacy.

  3. Time spent in post-operative recovery unit [ Time Frame: Post-operative day 0 ]
    The time the patient enters and leaves the post-operative recovery room will be recorded.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients between the ages of 18-80 years of age.
  • Patients presenting for ophthalmological surgery under general anaesthesia.
  • ASA I and II.
  • Literate in English, Setswana or Afrikaans.

Exclusion Criteria:

  • Patients outside the specified age range.
  • ASA III and above.
  • Patients with contra-indications to Laryngeal Mask Airway use during general anaesthesia.
  • Patients with severe medical or surgical conditions, who are expected to have prolonged admissions or ICU admissions.
  • Patients with uncontrolled psychiatric conditions like depression, schizophrenia, mania, dementia.
  • Patients with known allergy or adverse reaction to volatile anaesthetics.
  • Patients with known or suspected susceptibility to Malignant Hyperthermia.
  • Patients with incomplete records (Data Collection Form and QoR-15).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04188314


Locations
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South Africa
Sefako Makgatho Health Sciences University
Ga-Rankuwa, Gauteng, South Africa, 0221
Sponsors and Collaborators
Sefako Makgatho Health Sciences University
Investigators
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Principal Investigator: Charlé Steyl, MBChB DA FCA Sefako Makgatho Health Sciences University
  Study Documents (Full-Text)

Documents provided by Dr. Charle Steyl, Sefako Makgatho Health Sciences University:
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Responsible Party: Dr. Charle Steyl, Registrar in Department of Anaesthesiology, Sefako Makgatho Health Sciences University
ClinicalTrials.gov Identifier: NCT04188314    
Other Study ID Numbers: SMUREC/M/240/2019:PG
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: October 18, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonimized data will be made available in appendices/supplements to the final publication, for other researchers to review results, or to include in systematic reviews/meta-analyses. All IPD that underlie results in the publication will be made available, but no personal information of patients will be released.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The IPD will be available after writing up the study, it will be included in the MMed thesis as well as in appendices/supplements to final publication. The IPD will be available indefinitely.
Access Criteria: Anyone who accesses the final publication will be able to review the anonimized IPD through the appendices/supplements to the final publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Charle Steyl, Sefako Makgatho Health Sciences University:
Anesthesia: General
Outcome
Quality of Recovery Score
Anesthetics: Volatile
Desflurane
Isoflurane
Additional relevant MeSH terms:
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Desflurane
Isoflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs