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A study to compare the Magnesium sulphate nebulization versus intravenous infusion of Magnesium Sulphate in controlling post- intubation hemodynamic and stress response in adult patients undergoing scheduled surgeries.

Completed
Conditions
Medical and Surgical,
Registration Number
CTRI/2022/12/048494
Lead Sponsor
Department of anaesthesia and critical care
Brief Summary

It is a comparative study of preoperative magnesium sulphate nebulization versus intravenous infusion of magnesium sulphate in controlling post- intubation hemodynamic and stress response in adult patients undergoing elective surgeries.

A total number of 130 patients between the age 18 to 65, undergoing elective surgeries will be assigned into 2 groups, group I and group N by Block randomization with sealed envelope  system. There will be 65 patients in each group.

Group I will receive intravenous magnesium sulphate and group N will receive magnesium sulphate nebulization.

Primary objective will be to compare the changes in hemodynamic parameters between both groups in terms of Heart rate, Systolic blood pressure, Diastolic blood pressure, Mean arterial pressure, at different time intervals  following laryngoscopy and intubation: Baseline (T0), Post intervention/pre-induction(T1), Just before laryngoscopy(T2), 1 min.post-intubation(T3), 3 min.post-intubation(T4), 5 min.post-intubation(T5), 10 min.post-intubation(T6)

Secondary objectives will be to compare : 1)Serum Cortisol level: Baseline and Post intubation (15 min) 2)Serum magnesium level:Baseline and Post intubation (15 min), between both groups.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
130
Inclusion Criteria

Both male and female between the age of 18 to 65 will be included.

Exclusion Criteria
  • History of hypersensitivity to magnesium sulphate.
  • Anticipated difficult airway.
  • Patients on steroid therapy.
  • Patients on psychiatric medication.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes in Hemodynamic parameters following laryngoscopy and intubation in terms of:At different time intervals: | Baseline (T0) | Post intervention/pre-induction(T1) | Just before laryngoscopy(T2) | 1 min.post-intubation(T3) | 3 min.post-intubation(T4) | 5 min.post-intubation(T5) | 10 min.post-intubation(T6)
1)Heart rateAt different time intervals: | Baseline (T0) | Post intervention/pre-induction(T1) | Just before laryngoscopy(T2) | 1 min.post-intubation(T3) | 3 min.post-intubation(T4) | 5 min.post-intubation(T5) | 10 min.post-intubation(T6)
2) Systolic blood pressureAt different time intervals: | Baseline (T0) | Post intervention/pre-induction(T1) | Just before laryngoscopy(T2) | 1 min.post-intubation(T3) | 3 min.post-intubation(T4) | 5 min.post-intubation(T5) | 10 min.post-intubation(T6)
3)Diastolic blood pressureAt different time intervals: | Baseline (T0) | Post intervention/pre-induction(T1) | Just before laryngoscopy(T2) | 1 min.post-intubation(T3) | 3 min.post-intubation(T4) | 5 min.post-intubation(T5) | 10 min.post-intubation(T6)
4)Mean arterial pressureAt different time intervals: | Baseline (T0) | Post intervention/pre-induction(T1) | Just before laryngoscopy(T2) | 1 min.post-intubation(T3) | 3 min.post-intubation(T4) | 5 min.post-intubation(T5) | 10 min.post-intubation(T6)
Secondary Outcome Measures
NameTimeMethod
1)Serum Cortisol level2)Serum magnesium level

Trial Locations

Locations (1)

Vardhman Mahavir Medical College and Safdarjung hospital

🇮🇳

South, DELHI, India

Vardhman Mahavir Medical College and Safdarjung hospital
🇮🇳South, DELHI, India
DR POOJA KUMARI
Principal investigator
9319304774
kpooja004004@gmail.com

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