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临床试验/CTRI/2024/11/076109
CTRI/2024/11/076109招募中不适用

A STUDY TO COMPARE INTRANASAL DEXMEDETOMIDINE VERSUS MAGNESIUM SULPHATE AS AN ATOMIZER ON ATTENUATION OF HAEMODYNAMIC STRESS RESPONSE TO LARYNGOSCOPY UNDER GENERAL ANAESTHESIA

Smt Bhikiben Kanjibhai Shah Medical Institute and Research Center1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年11月6日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
56
试验地点
1
主要终点
To compare intranasal Dexmedetomidine versus magnesium sulphate as atomiser in attenuating heart

研究概览

简要总结

A study to compare intranasal Dexmedetomidine versus magnesium sulphate as an atomiser on attenuation of haemodynamic stress response to laryngoscopy under general anaesthesia.

Objective is to study the comparison between Dexmedetomidine and magnesium sulphate that how well it reduces heart rate and blood pressure when given intranasally via atomiser during laryngoscopy under general anaesthesia , to study post operative Ramsay sedation score and to observe if there are any side effects of the given drug.

Inclusion criteria Patients willing to sign written and informed consent, male or female patients between 18 to 65 years of age, patients belonging to American Society of Anaesthesiologists(ASA) physical status I and II, patients posted for elective surgeries under general anaesthesia.

Exclusion criteria

Patients unwilling to participate in study, patients with Body Mass Index greater than 30 Kg per metre square, patients having arrythmias, patient having heart rate less than 70 beats per minute, psychiatric patients, pregnancy and lactating women, patients belonging to the American Society of Anaesthesiologists (ASA) III and above, patients allergic to the study drugs, serum magnesium level greater than 2.5 meq per litre.

The study will be conducted on 56 adults aged 18 to 60 yrs belonging to grade

I & II of American Society of Anesthesiologists (ASA) classification who will

undergo elective surgeries under general anesthesia. They will be divided

into 2 equal groups with chit method.

Group D will recieve dexmedtomidine 2 mcg per kg in 2ml 0.9 percent NS and Group M will recieve magnesium

sulphate 1000mg in 2ml 0.9 percent NS through atomiser 30 minutes before induction by consultant anaesthesiologist. After completion of

atomisation following vitals will be observed : Heart Rate (HR) , Systolic Blood Pressure (SBP) , Diastolic

Blood Pressure (DBP) , Mean Arterial Pressure (MAP), SpO2 at baseline (Tb) , after test drug administration

(Td), during induction (Ti), during laryngoscopy and intubation (T0) , at 1 , 3 , 5 , 7 and 10 mintues after

intubation (T1), (T3), (T5), (T7), (T10) respectively. Post operatively sedation status will be assessed half hourly by RAMSAY Sedation Score (RSS) till a score

of 2 is achieved.

Site of Study Department of Anesthesiology, Dhiraj Hospital, S.B.K.S.

Medical Institute and Research Centre, Piparia, Waghodia, Vadodara

Study DesignProspective, double blinded and comparative study.

Study Duration The study will be initiated after obtaining permission from

institutional ethics committee till the achievement of the sample size or by

18 months whichever is earlier.

StatisticsNumerical 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 wherever appropriate for

between-groups comparisons, while for categorical variables; chi-square

test will be used. P value  less than 0.05 will be considered statistically significant.

Likely outomeThis prospective and comparative study will help

us to compare the efficacy between intranasal Dexmedetomidine and magnesium sulphate via atomiser in attenuating hemodynamic responses to laryngoscopy in patients undergoing surgeries under general anesthesia by

having better outcome 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 65.00 Year(s)(—)
性别
All

入选标准

  • Patients willing to sign written and informed consent.
  • Patients belonging to American Society of Anaesthesiologists(ASA) physical status I and II.
  • Patients posted for elective surgeries under general anesthesia.

排除标准

  • Patients unwilling to participate in study.
  • Patients with Body Mass Index greater than 30 Kg per m square.
  • Patients having arrythmias.
  • Patient having heart rate less than 70 beats per minute.
  • Psychiatric patients.
  • Pregnancy and lactating women.
  • Patients belonging to the American Society of Anaesthesiologists (ASA) III and above.
  • Patients allergic to the study drugs.
  • Serum magnesium level greater than 2.5mEq per l.

结局指标

主要结局

To compare intranasal Dexmedetomidine versus magnesium sulphate as atomiser in attenuating heart

时间窗: Haemodynamic responses will be observed at baseline, after test drug administratiion, during induction, during laryngoscopy and intubation and after intubation at 1,3,5,7 and 10 minutes.

rate and blood pressure during laryngoscopy under general anesthesia

时间窗: Haemodynamic responses will be observed at baseline, after test drug administratiion, during induction, during laryngoscopy and intubation and after intubation at 1,3,5,7 and 10 minutes.

次要结局

  • To compare intranasal Dexmedetomidine versus Magnesium sulphate as atomiser for observing post(operative sedation and side effects.)

研究者

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

Aditi Gupta

Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre

研究点 (1)

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