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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Post-operative Quality of Recovery score, assessed by QoR-15, change from baseline QoR-15 score pre-operatively
研究概览
简要总结
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.
详细描述
Aims & Objectives:
The aim of this study is to compare quality of recovery between desflurane and isoflurane inhalational anaesthesia. The primary objective of the study is to evaluate whether there is a difference between post-operative quality of recovery in patients who received desflurane and in patients who received isoflurane for maintenance of anaesthesia, using the QoR-15 score, a patient-rated outcome measure.
Isoflurane is the standard drug used at Dr. George Mukhari Academic Hospital theatre complex for maintenance of anaesthesia and will therefore be used as the drug for the control group. Desflurane will be used as the interventional drug. The minimal clinically important difference for the post-operative QoR-15 has been found to be 8. In other words, an intervention that changes the mean post-operative score by 8, can be interpreted to signify a clinically important improvement or deterioration.
The null hypothesis for this study is that there is no statistically significant difference in mean post-operative QoR-15 scores of patients receiving isoflurane and desflurane for maintenance of anaesthesia. The alternative hypothesis is that there is a statistically significant difference in mean post-operative QoR-15 scores between patients receiving isoflurane and desflurane.
A secondary objective will be to compare the consumption and relative cost of using isoflurane vs desflurane with a minimal or basal flow anaesthetic technique. This will be done by comparing the amount of vapour used in millilitre per hour between desflurane and isoflurane during basal flow anaesthesia. The relative cost of the vapour used will be estimated, based on the current government purchase price of isoflurane and desflurane.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Desflurane (Drug)
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.
干预措施: Isoflurane (Drug)
结局指标
主要结局
Post-operative Quality of Recovery score, assessed by QoR-15, change from baseline QoR-15 score pre-operatively
时间窗: 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.
次要结局
- Time spent in post-operative recovery unit(Post-operative day 0)
- 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)
研究者
Dr. Charle Steyl
Registrar in Department of Anaesthesiology
Sefako Makgatho Health Sciences University