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A study to compare decrease in stress response during skull pin insertion between intravenous dexmedetomidine and local infiltration of ropivacaine.

Comparison of intravenous dexmedetomidine with local infiltration of ropivacaine in attenuation of stress response to skull pin insertion in craniotomies.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017784
Enrollment
60
Registered
2019-02-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: G938- Other specified disorders of brain Health Condition 2: null- Patients of 18-65 years ASA grade 1 to 3 scheduled to undergo elective craniotomy under general anaesthesia requiring application of head- holder.

Interventions

Intervention1: Dexmedetomidine intravenous in comparison with local infiltration of ropivacaine: Two groups are selected one will be given intravenous dexmedetomidine (alph 2 agonist) loading dose 0.7

Sponsors

Department of anaesthesiology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade 1 to 3 undergoing elective craniotomy under general anaesthesia requiring application of head holder.

Exclusion criteria

Exclusion criteria: bradycardia( second or third degree heart block uncontrolled hypertention cardiac, renal or hepatic disease history of beta blocker intake glasgow coma scale pitutary disease known allergic to local anaesthetic or dexmedetomidine

Design outcomes

Primary

MeasureTime frame
Evaluation of efficacy of intravenous dexmedetomidine in decreasing skull pin insertion response i.e. alteration in heart rate, mean arterial pressure, BIS, perfusion index,serum cortisol, serum prolactin& blood glucose.Timepoint: Vitals are recorded at baseline, after induction, after intubation, 1, 3, 5 minutes after intubation, before and after study drug , before and after skullpin insertion, 1, 3, 5, 10, 15, 20 minutes after skullpin insertion . serum cortisol ,prolactin and blood sugar are measured baseline and 30 minutes after skullpin insertion.

Secondary

MeasureTime frame
systolic blood pressure, diastolic blood pressure, end tidal carbon dioxide level, SpO2, Fiso will be notedTimepoint: Recorded at baseline, after induction, after intubation, 1, 3, 5 minutes after intubation, before and after study drug , before and after skullpin insertion, 1, 3, 5, 10, 15, 20 minutes after skullpin insertion

Countries

India

Contacts

Public ContactDr Srishti malhan

Pt B D Sharma university of health sciences rohtak

drsrishtimalhan@gmail.com9996888324

Outcome results

None listed

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