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A simple method to prevent increase in blood pressure and heart rate during neurosurgery

Sterile Silicone Studs-A non-pharmacological modality for prevention of hemodynamic response to skull pin insertion: A pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047515
Enrollment
20
Registered
2022-11-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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: Sterile Silicone Studs: Patients will be randomly allocated to one of the two groups: 1. Fentanyl Only (GROUP FO) 2. Silicone Studs (GROUP SS) In the Fentanyl Only group, 1 µg/kg of fe
and one minute later, the head pins will be applied within a few minutes. In Silicone Studs group, Sterile silicone studs will be applied at the site of pin insertion and the head frame will be appli

Sponsors

PGiMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: This pilot study will be conducted in total twenty American Society of Anesthesiologist I-II patients scheduled for elective craniotomy

Exclusion criteria

Exclusion criteria: Patients with history of systemic hypertension or bradycardia, any systemic disease, beta-blocker use, known hypersensitivity to certain drugs, and previous craniotomy will be excluded

Design outcomes

Primary

MeasureTime frame
To compare the effect of non-pharmacological modality using Sterile Silicone Studs with fentanyl on the exaggerated hemodynamic response of skull pin insertion during neurosurgical procedures.Timepoint: T1, baseline; T2, before infiltration; T3, after infiltration; T4, prior to skull pin insertion; T5, 1 minute after skull pin insertion; T6, 5 minutes after skull pin insertion.

Secondary

MeasureTime frame
1. To assess the amount of rescue drug used in the form of propofol in both the groups after pin insertion. 2. To assess incidence of any associated complication with pin insertion like bleeding, hematoma formation, venous air embolism, skull fracture etc. at end of surgery. Timepoint: Nil

Countries

India

Contacts

Public ContactRajeev Chauhan

PGIMER

dr.rajeevchauhan@gmail.com7087009507

Outcome results

None listed

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