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A study on the effect of magnesium sulphate in addition to fentanyl in craniotomy

Effect of Intravenous Magnesium Sulphate in addition to Fentanyl on Haemodynamic Changes Following Skull Pin Insertion: A Randomised Controlled Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047408
Enrollment
50
Registered
2022-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: IV 0.9% Saline: Group A1 (Fentanyl Group) will receive 100 ml 0.9% saline infused intravenously over 15 minutes after anaesthetic induction and endotracheal intubation. Intervention2:

Sponsors

Sir Ganga Ram Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: BMI - 18.5 - 27.5 kg/m2 ASA Grade - 1 & 2

Exclusion criteria

Exclusion criteria: 1. Inability to obtain informed consent 2. Patient scheduled for emergency surgery 3. Pregnancy 4. Morbid obesity 5. Severe cardiac dysfunction 6. History of hypersensitivity of local or systemic anesthetic agents 7. Patients receiving beta-blockers or calcium channel blockers 8. Pacemaker in-situ 9. Deranged hepatic function 10. Deranged renal function 11. Deranged endocrine function 12. Known allergy to magnesium sulphate

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is to measure the difference in HR and SBP at prespecified time points in patients receiving IV magnesium sulphate with fentanyl versus IV fentanyl alone. Timepoint: Specified time points will be as follows: i. T0 - At the time of skull pin insertion ii. T1, T3, T5, T7, T10, T15 â?? At 01, 03, 05, 07, 10 and 15 minutes after skull pin insertion respectively.

Secondary

MeasureTime frame
Measure the requirement of rescue medication (IV lignocaine 1.5 mg/kg) in patients showing 20% increase in HR and SBP at 01 and 03 minutesTimepoint: 1 minute (T1) after skull pin insertion 3 minute (T3) after skull pin insertion

Countries

India

Contacts

Public ContactDr Rachna Bhutani

Sir Ganga Ram Hospital

rachnabhutani@ymail.com9811199484

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026