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临床试验/NCT06476600
NCT06476600已完成不适用

Opioid-based (OA) Versus Opioid-free Anaesthesia (OFA) for General Surgical Procedures in a Developing Country

Atif Shafqat1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
Mean total Quality of recovery (QoR-15) scores.

研究概览

简要总结

This is a prospective, randomized, parallel-group, double-blinded clinical trial. The study is approved by the DUHS institutional review board (IRB) and the trial will be registered at clinical trial registry. The participants of the study will be invited once they receive full trial information from the surgeons or the anesthetists during their pre-assessment visits. The study participants will join only for up to one day after the surgery (Post-operative day-1). The intervention consists of administration of dexmedetomidine infusion in opioid free anesthesia (OFA) group versus Nalbuphine IV bolus in opioid-based anesthesia (OA) group, five minutes before induction of anesthesia. For maintenance in OFA group dexmedetomidine infusion is to be continued whereas in OA group Nalbuphine IV bolus doses will be administered. Once the surgery is completed and after extubation and emergence from anesthesia, all the participants will be transferred to PACU from where they will be in turn discharged to the ward once they will fulfil the recovery discharge criteria. A multi-modal analgesia regimen along with a prophylactic antiemetic medication will be prescribed postoperatively to all the patients in the ward according to the standard protocol of the department.

详细描述

Opioid-based (OA) Versus Opioid-free Anaesthesia (OFA) for General Surgical procedures in a developing country.

Introduction:

Opioids and their synthetic derivatives were first used in anesthesia in 1962. They are now routinely dispensed via different routes of administration including oral, subcutaneous, intravenous, intramuscular, transdermal, epidural or intrathecal. In the last 20 years, the world has witnessed a substantial increase in the consumption of opioids. Opioids over prescription is one of the causative factors of opioid crisis in North America. The current global opioid crisis has multifactorial reasons, and this is gradually worsened due to the different waves of liberal opioid use. The ongoing opioid crisis has led to the development of alternative techniques like opioid sparing and opioid-free anaesthesia strategies. Owing to the well-researched and recognized opioid-based anaesthesia adverse effects, it is essential to develop alternative therapies to achieve the main benefits of opioids like analgesia and haemodynamic stability, while limiting the opioid related adverse effects. A sensible use of opioids in the perioperative period is important since vulnerable patients undergoing common general surgical procedures become chronic opioid users postoperatively. High doses of perioperative opioids can be associated with increased post-operative complications including respiratory depression, paralytic ileus, nausea and vomiting, difficulty voiding, pruritus, hyperalgesia and opioid tolerance. These can atypically increases the length of hospital stay (LOS) due to delayed patient recovery, prolonged PACU stay, delayed discharge and unanticipated hospitalization; thus overall compromising the quality of recovery (QoR) and putting unnecessary burden on both the patients' and hospital resources.

Opioid-free anesthesia(OFA) is a method that entirely eliminates the use of systemic, neuraxial, or intracavitary opioids. A less restrictive practice is opioid-sparing anesthesia (OSA), where small amounts of opioids are used. Patients suffering from chronic postsurgical pain, complex regional pain syndrome, cancer-related pain, and other opioid-tolerant patients may also benefit from OFA and OSA approaches.

OFA involves multimodal non-opioid analgesia, which uses sympatholytic drugs and non-opioid analgesics. These drugs can reduce or avoid the use of opioids in the postoperative period. A non-opioid multimodal analgesic method is intended at enhancing adjunctive options that is applying anesthetic techniques aiming different neuro-anatomical circuits and several neurophysiological mechanisms. Non-opioid analgesics include: alpha-2agonists (clonidine and dexmedetomidine), beta-blockers (esmolol), gabapentinoids (gabapentinand pregabalin), lidocaine (lidocaine hydrochloride), magnesium (magnesium sulfate), ketamine and dexamethasone. These drugs when used in combination acts synergistically and change the pathophysiology of nociception thus causes effective analgesia with minimal side effects.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signed informed consent from the participant.
  • All patients who are aged between 18 - 65 years.
  • American Society of Anaesthesiologists (ASA) classification of I and II
  • Elective Laparoscopic cholecystectomies.

排除标准

  • American Society of Anaesthesiologists (ASA) classification of III and above
  • Non-elective surgery
  • Body Mass Index > 35
  • Patients with regular prescription of Beta-blockers
  • Pregnant or breastfeeding women
  • Allergy to Opioids and/or other drugs used in the trial.
  • Chronic use of opioids or benzodiazepines
  • Chronic pain patients
  • Patients with cardiovascular, renal, hepatic or central nervous system diseases
  • Patients with psychiatric illness

研究组 & 干预措施

Opioid-free Anaesthesia

Active Comparator

干预措施: Dexmedetomidine injection (Drug)

Opioid-based Anaesthesia

Active Comparator

干预措施: Nalbuphine Injection (Drug)

结局指标

主要结局

Mean total Quality of recovery (QoR-15) scores.

时间窗: At 24 hours postoperatively

The QoR-15 is a validated patient reported outcome measure (PROM), which provides an effective assessment of post-operative recovery. It consists of a total of 15-items, grading each recovery item on a 10 - point numerical Likert scale with total QoR-15 score ranging from 0 (extremely poor recovery) to 150 (excellent recovery)

Mean total Quality of recovery (QoR-15) scores.

时间窗: At baseline preoperatively

The QoR-15 is a validated patient reported outcome measure (PROM), which provides an effective assessment of post-operative recovery. It consists of a total of 15-items, grading each recovery item on a 10 - point numerical Likert scale with total QoR-15 score ranging from 0 (extremely poor recovery) to 150 (excellent recovery)

次要结局

  • Anaesthesia and recovery clinical outcomes(Measured at start of anaesthesia till discharge from hospital)
  • Intraoperative haemodynamic stability(Measured from start to end of anaesthesia)
  • Anaesthesia and recovery clinical outcomes(Measured at end of anaesthesia in post anaesthesia care unit and at 24 hours postoperatively.)
  • Anaesthesia and recovery clinical outcomes(Measured at end of anaesthesia in post anaesthesia care unit or 24 hours postoperatively.)
  • Anaesthesia and recovery clinical outcomes(From Time of PACU admission to time of PACU discharge)
  • Anaesthesia and recovery clinical outcomes(From Time of theatre entrance to time of discharge from the hospital)

研究者

发起方
Atif Shafqat
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Atif Shafqat

Assistant Professor Anesthesiology

Dow University of Health Sciences

研究点 (1)

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