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临床试验/NCT04089592
NCT04089592已完成不适用

Comparison Of Dexmedetomidine and Fentanyl In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy.

Dow University of Health Sciences2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月15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
2
主要终点
Heart rate

研究概览

简要总结

Compare effects of intravenous dexmedetomidine and fentanyl in attenuation of intubation response in a patient undergoing laparoscopic cholecystectomy.

Compare the effects of intravenous dexmedetomidine and fentanyl in sedation, perioperative complications, and recovery in these patients.

Dexmedetomidine is comparatively a newer drug in countries like Pakistan. There is no research work available at the national level and scarcity of data at an international level with inconclusive outcomes. Our participation in the form of this research will add to scientific literature and step up ahead at the international level.

Fentanyl citrate is a narcotic analgesic interacting predominantly with the opioid μ receptor and exerting its principal pharmacological effect on CNS. Its primary action of therapeutic value is analgesia and sedation. It is extensively used for anesthetic and analgesic most often in operating room and ICU.

详细描述

This is double-blind, a single centered randomized clinical trial which is based on assessing the hemodynamic stability provided by our study drugs during laryngoscopy and intubation in a patient undergoing laparoscopic cholecystectomy. In addition to that this study will assess the perioperative complication and postoperative recovery in these patients. Laparoscopy has now become the standard technique of choice for cholecystectomy which results in pathophysiological changes characterized by an increase in arterial pressure and heart rate (HR). Many types of research have been done in an attempt to minimize adverse effects by adding adjuvants to the conventional method of general anesthesia. Our research is also based on this aim. The objective of this study to determine the hemodynamic stability during laryngoscopy and intubation, peri-operative complication and post-operative recovery. The patients will be divided into two groups randomly and will be given the desired drugs via intravenous line by on floor consultant anesthetist who will be blinded to the drug. The study subjects' hemodynamics will be observed until 10 minutes of intubation. Any perioperative complication will be noted. The subjects will also be followed postoperatively in recovery to check there sedation score and recovery (Aldrete score) will be noted after 10 minutes after the patient shifted to recovery.

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, Investigator)

盲法说明

Patient meeting the inclusion criteria will be randomly allocated divided into two groups by chit paper method A, B (30 participants in each group).

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA-I and ll patients
  • Male and female patient of age 20-70 years.
  • Undergoing Elective laparoscopic cholecystectomy.

排除标准

  • Pregnant and lactating females
  • Short thick neck with anticipated difficult intubation.
  • Obese patients.
  • Narcotic addicts.
  • Full stomach patient or with higher chances of aspiration.
  • Patient allergic to any of the study medications.
  • Patients high risk to develop serotonin syndrome. (patient taking an antidepressant and other psychomotor medications.

研究组 & 干预措施

Dex Group

Experimental

intravenous dexmedetomidine 0.6mcg/kg in 100ml normal saline 0.9%

干预措施: Dexmedetomidine (Drug)

Fent Group

Experimental

intravenous fentanyl at 2mcg/kg in 100ml saline

干预措施: Fentanyl (Drug)

结局指标

主要结局

Heart rate

时间窗: at 10 minutes

Hemodynamic response(induction) will be assessed on different point in time during procedure

Systolic blood pressure

时间窗: 10 minute

Hemodynamic response(induction) will be assessed on different point in time during procedure

Diastolic blood pressure

时间窗: at 10 minutes

Hemodynamic response(induction) will be assessed on different point in time during procedure

Mean atrial pressure

时间窗: at 10 minute

Hemodynamic response(induction) will be assessed on different point in time during procedure

SpO (oxygen saturation)

时间窗: at 10 minute

Hemodynamic response(induction) will be assessed on different point in time during procedure

次要结局

  • Complications(Will be assessed within Hospital stay at follow for 1 week)
  • Hypertension(Will be assessed within Hospital stay at follow for 1 week)
  • Ramsey score(at 10 minutes)
  • Post operative vomiting and nausea(Will be assessed within Hospital stay at follow for 1 week)
  • Hypotension(Will be assessed within Hospital stay at follow for 1 week)
  • Regurgitation(Will be assessed within Hospital stay at follow for 1 week)
  • Laryngospasm(Will be assessed within Hospital stay at follow for 1 week)
  • Bradycardia(Will be assessed within Hospital stay at follow for 1 week)
  • Aldrete score(at 10 min)

研究者

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

Sana Urooj

Assistant Professor

Dow University of Health Sciences

研究点 (2)

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