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临床试验/NCT03029715
NCT03029715已完成不适用

Comparative Study Between Inhalational Anaesthesia and Total Intravenous Anaesthesia (TIVA) With Dexmedetomidine for Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy

Menoufia University0 个研究点目标入组 100 人开始时间: 2014年2月最近更新:
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
100
主要终点
Analgesic Requirements.

研究概览

简要总结

Background: Laparoscopic sleeve gastrectomy is commonly done with total intravenous anaesthesia (TIVA) or balanced anaesthesia using intravenous and an inhalation agent. It is still unclear which anaesthesia regimen is better for this group of patients. The present study was carried out to compare the use of inhalation anaesthesia technique using desflurane and TIVA using propofol and dexmedetomidine.

Methods: This randomized controlled trial was carried out on 100 morbidly obese patients undergoing laparoscopic sleeve gastrectomy. The patients were randomized into two equal groups, inhalational group and TIVA group for anaesthesia maintenance. All patients received general anaesthesia and induced with propofol, remifentanil and cis-atracurium. In inhalation group, anaesthesia was maintained by desflurane in oxygen air mixture while in TIVA group anaesthesia was maintained by intravenous propofol and dexmedetomidine infusion. Intra-operative vital signs and anaesthesia recovery time were recorded. Post-operative nausea, vomiting, pain score, analgesic consumption, the onset of bowel movement, and post-anaesthetic care unit (PACU) stay were studied for both groups.

详细描述

After obtaining the ethics committee approval of El Menoufia University hospital and the informed written consent from the patients, a hundred morbidly obese patients scheduled for sleeve gastrectomy were recruited for the study. Patients with history of cardiac comorbidity, chronic obstructive lung disease, drug abuse, expected difficult intubation patients, and patients with history of allergy to the study drugs were excluded from the study. Patients from 30 to 50 years old of both sexes were randomly allocated using computerized software into two groups, fifty patients in each group. Patients in inhalation group received intra-operative inhalational anaesthetic while patients in TIVA group received TIVA for anaesthetic maintenance.

All patients received a routine premedication with oral sodium citrate 15ml [0.3 molar (1.16gm)] and intravenous (IV) 4mg ondansetron fifteen minutes before induction. Patients in both groups were connected to the routine monitoring and bispectral index (BIS) upon arrival to theatre. Anaesthesia induction for both groups was carried out by 0.5-1 mcg kg -1 remifentanil, 2-3mg kg-1 propofol, and 0.6 mg kg-1 rocuronium. Endotracheal intubation was done with the appropriate tube size.

In the inhalational group, anaesthesia was maintained by desflurane in low flow oxygen air mixture 60/40%. In the TIVA group, anaesthesia was maintained using propofol 8-12 mg kg-1 h-1 and dexmedetomidine 0.5-1ugkg-1h-1. Remifentanil infusion of 0.05-2 µg kg-¹min-¹ was administered for both groups. Muscle relaxation was maintained in both groups by rocuronium infusion at a rate of 10-12ug kg1min-1. Depth of anaesthesia was monitored by bispectral index and anaesthetics were adjusted in both groups to obtain BIS of 40 to 60 by giving boluses of 0.5ug kg-1 remifentanil. The total boluses of intra-operative remifentanil were recorded. At the end of the procedure all patients received 0.6mg atropine and sugammadex 16mg kg-1 to reverse the effect of rocuronium. Patients were extubated and transferred to the post-anaesthetic care unit (PACU).

Post-operative pain was monitored using visual analogue score (VAS) at PACU. Morphine sulphate 2 to 3 mg was given if the VAS was > 4. Intravenous paracetamol 1gm and/or ketorolac 30 mg were given eight hourly intravenously if needed (VAS ≥3). Post-operative ondansetron 4mg every eight hours was given if required.

Haemodynamics including heart rate and mean arterial blood pressure (MABP) were recorded as a baseline and every fifteen minutes intra-operatively. Recovery time from anaesthesia using Aldrete score was recorded (the time from cessation of all anesthetics until complete recovery). 10 The incidence of post-operative nausea and vomiting, post-operative analgesic requirements, and the duration of PACU stay were recorded. Post-operative pain assessment using VAS from 0 to 10, where 0 means no pain and 10 is the worst pain the patient experienced. VAS was recorded at full recovery, every 15 minutes in PACU until discharge PACU. Time of onset of post-operative bowel movement was recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Morbid obese scheduled for sleeve gastrectomy.

排除标准

  • Patients refusal and allergy to drugs used.

研究组 & 干预措施

Intravenous anaesthesia

Other

Propofol Dexmedetomidine Remifentanil

干预措施: Propofol (Drug)

Intravenous anaesthesia

Other

Propofol Dexmedetomidine Remifentanil

干预措施: Remifentanil (Drug)

Intravenous anaesthesia

Other

Propofol Dexmedetomidine Remifentanil

干预措施: Dexmedetomidine (Drug)

Inhalation anaesthesia

Other

Desflurane Remifentanil

干预措施: Remifentanil (Drug)

Inhalation anaesthesia

Other

Desflurane Remifentanil

干预措施: Desflurane (Drug)

结局指标

主要结局

Analgesic Requirements.

时间窗: Within one hour after surgery

Total paracetamol consumption.

次要结局

  • The Intra-operative Mean Arterial Blood Pressure.(During operation and follow-up, an average of 2 hours)

研究者

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

Dr Ezzeldin Ibrahim

Assistant Professor in anaesthesia, intensive care, and pain medicine.

Menoufia University

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