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临床试验/CTRI/2024/10/075366
CTRI/2024/10/075366尚未招募不适用

A comparative study of clonidine and gabapentin as an oral premedication on hemodynamic response to laryngoscopy and tracheal intubation

Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年10月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
To compare tablet clonidine and gabapentin as given oral premedication premedication , in attenuating exaggerated hemodynamic response during laryngoscopy and tracheal intubation.

研究概览

简要总结

A comparative study of clonidine and gabapentin as an oral premedication on hemodynamic response to laryngoscopy and tracheal. intubation.

To compare the clonidine and gabapentin given orally as premedication, reduces changes in blood pressure and heart rate during laryngoscopy and tracheal intubation.

Inclusion Criteria:

·      Patients will be willing to sign written and informed consent.

·      Male or female patients between 18 to 60 years of age.

·      Patients will belonging to American Society of Anaesthesiologists (ASA) physical status   I and II.

·      Patients will be posted for elective surgeries under general anaesthesia.

Exclusion Criteria:

·      Patients unwilling to participate in the study.

·      Patients with Body Mass Index ≥ 30 kg/m2.

·      Patients with history of muscular disorder ; myositis, myoclonus, myasthenia gravis.

·      Patients with cardiovascular diseases, arrhythmias, heart blocks, or taking beta blockers.

·      Patients with cerebrovascular, hepatic and renal diseases.

·      Psychiatric patients.

·      Patients will blur vision

·      Patients with history of allergy to an α-2 adrenergic agonist

·      Pregnancy & lactating women.

Site of Study: Department of Anaesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and Research Centre, Piparia, Waghodia, Vadodara, Gujarat.

Study Design- comparative and randomized study

METHODOLOGY

·       Patients will be kept Nil Per Orally (NPO) 6 hours and 4 hours prior to surgery for solids and clear liquids respectively, before surgery.

 Â·       Written informed consent will be taken from the patients who are fulfilling the criteria.

 Â·       On the day of operation, all the participants will be shifted to preoperative area 1 hour before the operation time. All standard monitors like pulse oximeter, non-invasive blood pressure (NIBP) will be attached and baseline haemodynamic parameters will be recorded in preoperative room. An 18-gauge (18G) peripheral venous cannula will be secured and IV Ringer’s Lactate solution will be administered as maintenance fluid (80ml/hr) through it.

  Â·       The consultant anaesthesiologist will be give orally tablet clonidine 0.2mg 30 minutes prior to induction of general anaesthesia in Group Dcpatients.

 Â·       And in Group Dgpatients the consultant anaesthesiologist will administer orally tablet gabapentin 800mg 30 minutes before induction of anaesthesia

LIKELY OUTCOME / BENEFITS OF THE STUDY

This study will help us to compare the efficacy between oral clonidine and gabapentin in  hemodynamic responses to laryngoscopy and endotracheal intubation in patients undergoing surgeries under general  anaesthesia and will enable us to know which drug will given orally  is most beneficial in giving balanced general anaesthesia by having better outcomes in hemodynamics.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •Patients will be willing to sign written and informed consent.
  • •Male or female patients between 18 to 60 years of age.
  • •Patients will belonging to American Society of Anaesthesiologists (ASA) physical status I and II.
  • •Patients will be posted for elective surgeries under general anaesthesia.

排除标准

  • •Patients unwilling to participate in the study.
  • •Patients with Body Mass Index ≥ 30 kg/m
  • •Patients with history of muscular disorder ; myositis, myoclonus, myasthenia gravis.
  • •Patients with cardiovascular diseases, arrhythmias, heart blocks, or taking beta blockers.
  • •Patients with cerebrovascular, hepatic and renal diseases.
  • •Psychiatric patients.
  • •Patients will blur vision •Patients with history of allergy to an α-2 adrenergic agonist •Pregnancy & lactating women.

结局指标

主要结局

To compare tablet clonidine and gabapentin as given oral premedication premedication , in attenuating exaggerated hemodynamic response during laryngoscopy and tracheal intubation.

时间窗: Baseline vitals(HR ,SBP ,DBP,MAP) | After Test drug administration | After induction | At laryngo- scopy and intubation | After Intubation (In minutes) | 1 min,3 min,5 min,7min,10min

次要结局

  • Check for analgesic ,opioids requirement.(During laryngoscopy and tracheal intubation and until 10 minutes after it.)

研究者

发起方
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Devendra Joshi

Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre

研究点 (1)

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