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临床试验/CTRI/2025/04/083894
CTRI/2025/04/083894尚未招募不适用

A prospective comparative study of effects of intravenous dexmedetomidine versus intravenous magnesium sulfate in attenuating hemodynamic stress responses during laryngoscopy and endotracheal intubation in spine surgeries.

Smt Bhikiben Kanjibhai Shah Medical Institute and Research Cen1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年4月14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
52
试验地点
1
主要终点
This prospective and observational study will help us to compare the efficacy of intravenous Dexmedetomidine versus intravenous Magnesium sulphate for attenuation of the pressor response to larngoscopy and endotracheal intubation and will enable us to know which of the two drugs is most beneficial in providing better attenuation of the hemodynamic response to larngoscopy and endotracheal intubation.

研究概览

简要总结

A PROSPECTIVE COMPARATIVE STUDY OF EFFECTS OF INTRAVENOUS DEXMEDETOMIDINE VERSUS INTRAVENOUS MAGNESIUM SULFATE IN ATTENUATING HEMODYNAMIC STRESS RESPONSES DURING LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION IN SPINE SURGERIES

**Objective:**To compare  the efficacy of intravenous Dexmedetomidine versus Magnesium sulfate in attenuating heart rate during laryngoscopy and endotracheal intubation in patients undergoing surgeries under general anasethesia.

To compare the efficacy of intravenous Dexmedetomidine versus Magnesium sulfate in attenuating blood pressure during

laryngoscopy and endotracheal intubation in patients undergoing surgeries under general anasethesia.

INCLUSION CRITERIA

Patients willing to sign written & informed consent.

Male or female patients between ages of 18 to 60 years.

Patients belonging to American Society of Anesthesiologists (ASA) physical status I and II.

Patients posted for elective spine surgeries under general anesthesia

EXCLUSION CRITERIA

Patients unwilling to participate in the study.

Patients with cardiovascular, cerebrovascular, hepatic and renal diseases.

Patients having arrhythmias or heart block.

Psychiatric patients.

Pregnancy & lactating women.

Patients taking beta blockers.

History of allergy to the study drugs.

Anticipated difficult airway.

BMI greater than 30

Patient having Neuromuscular disease

Serum magnesium level greater than 2.5mEq per L

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

Study Design- Prospective comperative study

Study Duration- The study will be initiated after obtaining the permission from institutional ethics committee till the achievement of the sample size or 18 months whichever is earlier.

Data will be collected & tabulated. Numerical variables will be presented as mean & standard deviation (SD) while categorical variables will be presented as frequency and percentage. As regard to numerical variables; tests like unpaired student–t test and/or ANNOVA will be used whenever appropriate for between-groups comparisons, while for categorical variables; chi–square test will be used. p value <0.05 will be considered statistically significant.

LIKELY OUTCOME

This prospective and observational study will help us to compare the efficacy of  intravenous

Dexmedetomidine versus  intravenous Magnesium sulphate for attenuation of the pressor response to

larngoscopy and endotracheal intubation and will enable us to know which of the two drugs is most

beneficial in providing better attenuation of the hemodynamic response to larngoscopy and endotracheal

intubation.

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 willing to sign written & informed consent.
  • Male or female patients between ages of 18 to 60 years.
  • Patients belonging to American Society of Anesthesiologists (ASA) physical status I and II.
  • Patients posted for elective spine surgeries under general anesthesia.

排除标准

  • Patients unwilling to participate in the study.
  • Patients with cardiovascular, cerebrovascular, hepatic and renal diseases.
  • Patients having arrhythmias or heart block.
  • Psychiatric patients.
  • Pregnancy & lactating women.
  • Patients taking beta blockers.
  • History of allergy to the study drugs.
  • Anticipated difficult airway.
  • BMI greater than 30 Patient having Neuromuscular disease Serum magnesium level greater than 2.5mEq per L.

结局指标

主要结局

This prospective and observational study will help us to compare the efficacy of intravenous Dexmedetomidine versus intravenous Magnesium sulphate for attenuation of the pressor response to larngoscopy and endotracheal intubation and will enable us to know which of the two drugs is most beneficial in providing better attenuation of the hemodynamic response to larngoscopy and endotracheal intubation.

时间窗: Monitoring of parameters i.e. HR, SBP, DBP, MAP, SPO2 will be noted at baseline, after administration of test drug, after induction, during laryngoscopy and intubation and at 1,3,5 minutes after intubation.

次要结局

  • To study sedation score after extubation or any(side effects.)

研究者

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

Dr Karnati Eshwar

Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre

研究点 (1)

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