Comparing silicone studs and scalp injection with lignocaine to reduce stress and heart rate blood pressure changes during pin placement in the skull in children undergoing brain surgery

Comparison of Sterile Silicone Studs and scalp infiltration with lignocaine in attenuation of hemodynamic and stress response to skull pin insertion during craniotomy in Paediatric Neurosurgical patients - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/073937

Enrollment

Registered

2024-09-13

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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 Health Condition 2: F59- Unspecified behavioral syndromes associated with physiological disturbances and physical factors

Interventions

Intervention1: Silicone stud: Silicone Studs (SS), designed to alleviate the pressure impact of skull pins in pediatric patients. As far as were aware, this represents the inaugural instance of implem

Eligibility

Inclusion criteria

Inclusion criteria: ASA I and II patients Aged between 0 to 12 years Male and Female

Exclusion criteria

Exclusion criteria: Patient refusal Inability to give informed consent Patient with h/o of bradycardia ,allergy to medication including propofol, fentanyl, and dexmedetomidine

Design outcomes

Primary

Measure	Time frame
Comparison of Sterile Silicone Studs and Scalp Infiltration with Lignocaine in prevention of hemodynamic and stress response to Skull pin insertion during Craniotomy in Pediatric Neurosurgical Patients.Timepoint: Baseline, 1 min prior to pin insertion, At the time of pin insertion, 1 min after insertion, 3 min after pin insertion, 5 min after pin insertion, 10 min after pin insertion	—

Secondary

Measure	Time frame
Comparison of Sterile silicone Studs & lignocaine infiltration in attenuation of hemodynamic response in terms of heart rate & blood pressure to skull pin insertion during craniotomy. To assess incidence of any associated complication with pin insertion like bleeding, hemotoma formation, venous air embolism , skull fractures. Timepoint: Baseline, 1 min prior to pin insertion, At the time of pin insertion, 1 min after insertion, 3 min after pin insertion, 5 min after pin insertion, 10 min after pin insertion	—

Measure

Time frame

Comparison of Sterile silicone Studs & lignocaine infiltration in attenuation of hemodynamic response in terms of heart rate & blood pressure to skull pin insertion during craniotomy. To assess incidence of any associated complication with pin insertion like bleeding, hemotoma formation, venous air embolism , skull fractures. Timepoint: Baseline, 1 min prior to pin insertion, At the time of pin insertion, 1 min after insertion, 3 min after pin insertion, 5 min after pin insertion, 10 min after pin insertion

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Countries

India

Contacts

Public ContactAman Prakash

Postgraduateinstituteofmedicaleducationandresearch,CHANDIGARH

Dr.RajeevChauhan@gmail.com7087422950

Outcome results

None listed

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