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

NCT04188314 | Completed

• 1 other identifier: SMUREC/M/240/2019:PG
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Recovery; Anesthesia Recovery Period

Keywords

Anesthesia: General; Outcome; Quality of Recovery Score; Anesthetics: Volatile; Desflurane; Isoflurane

Outcome Measures

Primary Outcomes (1)

• Post-operative Quality of Recovery score, assessed by QoR-15, change from baseline QoR-15 score pre-operatively

  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.

  Pre-operative day 0 and Post-operative day 1

Secondary Outcomes (3)

• Consumption of anaesthetic vapour with basal anaesthetic technique

  Intraoperative day 0

• Cost of anaesthetic vapour with basal to minimal flow anaesthetic technique

  Intraoperative day 0

• Time spent in post-operative recovery unit

  Post-operative day 0

Study Arms (2)

Desflurane Interventional Group

EXPERIMENTAL

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

Isoflurane Control Group

ACTIVE COMPARATOR

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

Interventions

Desflurane DRUG

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.

Also known as: Suprane

Desflurane Interventional Group

Isoflurane DRUG

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.

Also known as: Forane

Isoflurane Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sefako Makgatho Health Sciences University: lead

Study Sites (1)

Sefako Makgatho Health Sciences University

Ga-Rankuwa, Gauteng, 0221, South Africa

Location

Related Publications (1)

• Steyl C, Kluyts HL. A randomised controlled trial comparing quality of recovery between desflurane and isoflurane inhalation anaesthesia in patients undergoing ophthalmological surgery at a tertiary hospital in South Africa (DIQoR trial). BJA Open. 2023 Dec 20;9:100246. doi: 10.1016/j.bjao.2023.100246. eCollection 2024 Mar.

  PMID: 38193018 DERIVED

MeSH Terms

Interventions

Desflurane; Isoflurane

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Charlé Steyl, MBChB DA FCA

  Sefako Makgatho Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registrar in Department of Anaesthesiology

Model Details: 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.

Study Record Dates

• First Submitted: October 27, 2019
• First Posted: December 5, 2019
• Study Start: February 20, 2020
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

ZA (1)