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临床试验/NCT04525274
NCT04525274已完成不适用

Comparative Study Between Intraperitoneal Dexmedetomidine Versus Ketamine With Bupivacaine For Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy

Zagazig University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年10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
入组人数
60
试验地点
1
主要终点
change in assessment of postoperative shoulder, abdominal and incisional pain

研究概览

简要总结

Post-laparoscopic sleeve pain management is essential for early mobilization of the patient and so on decrease post-operative complication. The use of opioids is associated with adverse effects such as nausea, pruritus, sedation, and occasionally respiratory depression.

Previous studies stated that intraperitoneal instillation of bupivacaine alone has been used to reduce acute postoperative abdominal and shoulder pain allow early mobilization and decrease postoperative opioid requirements and its complications.

In this study the investigators will compare between intraperitoneal instillation of dexmedetomidine with bupivacaine versus ketamine with bupivacaine in patients undergoing laparoscopic sleeve gastrectomy under general anesthesia regarding to postoperative pain relief to reduce morbidity and mortality.

详细描述

Obesity is a serious condition in developed and developing countries occur due to some hormonal disorder or due to reduce energy expenditure with increasing energy uptake [1]. Nowadays, obesity considered the second cause of deaths after smoking all over the world [2].

Severe obesity increase the incidence of many chronic disease such as (diabetes mellitus, hypertension, cardiovascular diseases and others) [3]. This leads to substantial morbidity, early mortality [4], impaired quality of life [5] and excess healthcare expenditures [6].

Laparoscopic bariatric surgery is the most recommended and effective long-term treatment for morbid obesity (which body mass index (BMI) ≥40 kg/m2) and obesity-related complication [7].

Postoperative pain management after laparoscopic sleeve still considers a major challenge. As many of the patients express moderate-to-severe pain in postoperative period [8]. Causes of postoperative pain include inflammation of the peritoneum, intra-abdominal cavity stretch and irritation of diaphragm by carbon-dioxide (CO2) remains in the abdominal cavity [9].

Multimodal analgesia regimens such as parenteral opioids, nonsteroidal anti-inflammatory drugs and intraperitoneal instillation of different drugs such as local anesthetic drugs alone or with adjuvants like; opioid and α2 agonists' drugs such as clonidine and dexmedetomidine have been tried to reduce overall pain and postoperative complications of patients undergoing laparoscopic surgeries [8, 9].

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

triple blinded (patient, surgeon and outcomes assessor)

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient acceptance.
  • Age 21-60 years old.
  • Sex both male and female.
  • BMI ≥40 kg/m2
  • ASA II and ASA III.
  • Scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia.

排除标准

  • Patients with known history of allergy to study drugs.
  • Patients with uncontrolled diabetes mellitus.
  • Psychological and mental disorders.
  • Severe hypertensive, cardiac, hepatic and renal patients.
  • Patients on opioid or sedative use.

研究组 & 干预措施

control group

Placebo Comparator

patient will receive 40 ml bupivacaine 0.25% + 5 ml normal saline with a total volume of 45 ml to be installed intraperitoneally.

干预措施: normal saline (Drug)

dexmedetomidine group

Active Comparator

patient will receive 40 ml bupivacaine 0.25% + 1 µg/kg dexmedetomidine diluted in 5 ml normal saline with a total volume of 45 ml to be installed intraperitoneally.

干预措施: dexmedetomidine (Drug)

ketamine group

Active Comparator

patient will receive 40 ml bupivacaine 0.25% + 0.5 mg/kg ketamine diluted in 5 ml normal saline with a total volume of 45 ml to be installed intraperitoneally.

干预措施: Ketamine (Drug)

结局指标

主要结局

change in assessment of postoperative shoulder, abdominal and incisional pain

时间窗: at 1, 2, 4, 6, 12 and 24 hours postoperatively

will be assessed by visual analogue scale (VAS) scale, On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.

次要结局

  • Time of first request of analgesia(within 24 hour postoperative)
  • Total rescue analgesic requirement(during the first postoperative 24 hours)
  • The incidence of postoperative nausea and vomiting (PONV)(during the first postoperative 24 hours)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Rehab Abd-Allah Wahdan

lecturer of anesthesia and surgical intensive care

Zagazig University

研究点 (1)

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