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临床试验/NCT05850832
NCT05850832已完成2 期

Efficacy of Esmolol Versus Magnesium Sulphate on Quality of Recovery in Patients Undergoing Laparoscopic Cholecystectomy: Randomized Controlled Study

Alexandria University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
1
主要终点
times needed for spontaneous eye opening

研究概览

简要总结

sixty patients, of both sexes, of ASA I or II planned for ambulatory laparoscopic cholecystectomy under general anaesthesia were engaged into 2 groups. Esmolol group were given 1 mg/kg loading dose followed by 30 μg/kg/min throughout the surgery, whereas magnesium sulphate (MgSo4) group were given loading dose 40 mg/kg over 15 mins then maintenance dose 15 mg/kg/h till end of surgery. General anaesthesia was standardized and postoperative analgesia included fentanyl. Variables denoting immediate recovery from anaesthesia, pain score and time of stay in PACU were recorded. White-Song score ≥ 12 along with pain score < 4 were the cut off levels for patients' discharge from PACU.

详细描述

The primary end point of this study are variables concerning immediate postoperative recovery like times needed for spontaneous eye opening, tongue protrusion, extubation and ability of the patient to mention name. Secondary outcomes includes pain assessment using pain numerical scale, time for first call to analgesia, total amount of intraoperative fentanyl consumption, total dose of rescue antiemetics and time of discharge from PACU.

Following attaining Ethical committee approval and patient's written consent- after broad explanation of the entire procedure- 60 patients aged 20-65 years of both sexes, of American society of Anesthesiologists (ASA) physical status I and II planned for ambulatory laparoscopic cholecystectomy under general anaesthesia were engaged to this study.

Exclusion criteria were: patients on chronic use or known allergic to the study drugs, body mass index >35 kg/m2, significant organ dysfunction, cardiac dysrhythmias, neuromuscular diseases, liver or renal disease, known asthma or reactive airway diseases.

Preoperatively all participants were carefully evaluated via detailed history taking, thorough physical examination and routine investigations (complete blood picture, renal function tests and liver functions). Also, they were instructed in the utilization of the verbal rating scale (VRS).

For blinding purpose, both the study drugs were prepared by an anaesthesiologist not enrolled in data assumption. Accordingly, for every case 2 prefilled syringes; one 10-ml for loading dose and the other 20-ml for maintenance infusion were given unidentified to the operating theater containing either Esmolol (Esmolol hydrochloride; Baxter Healthcare Corp., Deerfield, USA) or MgSo4 ( Egyptian international pharmaceutical indust., EYGPT).

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • patients aged 20-65 years of both sexes

排除标准

  • patients on chronic use or known allergic to the study drugs
  • body mass index >35 kg/m2,
  • significant organ dysfunction, cardiac dysrhythmias, neuromuscular diseases
  • liver or renal disease,
  • known asthma or reactive airway diseases.

研究组 & 干预措施

Group E

Active Comparator

Esmolol group: patients received loading dose 1 mg/kg followed by maintenance dose of 30 μg/kg/min throughout the surgery

干预措施: Esmolol (Drug)

Group M

Active Comparator

Magnesium sulphate group: patients received loading dose 40 mg/kg over a period of 15 mins and maintenance 15 mg/kg/h throughout the surgery.

干预措施: Magnesium sulfate (Drug)

结局指标

主要结局

times needed for spontaneous eye opening

时间窗: immediately postoperative

time passed from end of procedure until the patient open his eyes

次要结局

  • total amount of intraoperative fentanyl consumption(immediately postoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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