Effect of addition of different drugs before layngoscopy and intubation to prevent rise in BP and heart rate in patients undergoing general anaesthesia

Completed

• Conditions: General Surgery

• Registration Number: CTRI/2018/03/012744
• Lead Sponsor: SGRDIMSR

Brief Summary

After taking an approval from hospital ethics committee and a writteninformed consent, 120 patients in the age group of 18-60 years of either sex,ASA grade I and II were allocated into three groups of 40 patients each in arandomized double blind manner with every patient receiving 100 ml of test drugsolution via intravenous route as follows:

**Group I (n=40):**Dexmedetomidine 1 µg/kg in normal saline making a total of 100ml

**Group II (n=40):**Magnesium sulphate 30mg/kg in normal saline making a total of 100ml

**Group III (n=40):**Normal saline to a total of 100ml

Theresults were compiled and compared statistically in terms of demographics,duration of surgery, sedation scores, BIS values, hemodynamic parameters-heart rate, systolic blood pressure, diastolic blood pressure, mean arterialpressure and ECG changes and any adverseeffects. All the groups were comparable in terms of age, sex and ASA status. Doseof propofol required for intubation and the dose of vecuronium requiredintraoperatively were also recorded.

To summarize-

1.    Lower BIS levels themselves facilitatedsmooth tracheal intubation without any pressor responses as seen in placebogroup.

2.    Use of both dexmedetomidine andmagnesium sulphate may prove beneficial in theanaesthesia settings where BIS monitoring facilities are lacking, due to their BP& HR lowering properties.

3.    However,both the adjuvants i.e. dexmedetomidine and magnesium sulphate reduced the timeto reach BIS 40-60 by producing sedative effects, butRamsay Sedation Scores were comparatively higher in dexmedetomidine group.

4.    Sparingof propofol was exceptionally more in dexmedetomidine treated study population.

5.    MgSO4 although caused lesspropofol sparing effect but had an additional vecuronium sparing effect.

6.    In balanced anaesthesia, titration of propofol andother anaesthetic agents guided by BIS index, decreases the incidence of intraoperative awareness, decreases thedose of propofol and significantly improves the recovery.

7.    Use of BIS monitoring as an objective marker forassessing the level of consciousness and as a guideto determine end points of anaesthetic requirements, can prevent the over-infusion or under-dosage of anesthetic drugs.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-30
• Study Completion: 2017-08-24
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

ASA physical status I and II Scheduled for elective surgery under GA.

Exclusion Criteria

• ASA III and above 2.
• Major hepatic, renal or cardiovascular dysfunction 3.
• Pregnancy, PIH 4.
• Patients on anticoagulation therapy 5.
• Postural hypotension 6.
• Anticipated difficult airway 7.
• Uncontrolled hypertension and myocardial disease 8.
• Surgeries involving anticipated major blood losses and fluid shifts 9.
• Patients with drug allergies.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Attenuation haemodynamic stress response to laryngoscopy and intubation	15 minutes after study drug infusion till 30 minutes post-intubation

Secondary Outcome Measures

Name	Time	Method
Propofol and muscle relaxant sparing effect of dexmedetomidine and magnesium sulphate, respectively	15 minutes after study drug infusion till whole of intraoperative period

Trial Locations

Locations (1)

SGRDIMSR, Amritsar; 🇮🇳 Amritsar, PUNJAB, India

SGRDIMSR, Amritsar

🇮🇳Amritsar, PUNJAB, India

Dr Ruchi Gupta

Principal investigator

9814320805

drruchisgrd@gmail.com