comparing lignocaine spray and distilled water to control blood pressure and heart rate changes during tonsil surgery

Evaluation of lignocaine vs distilled water spray to decrease hemodynamic changes after application of mouth gag in patients undergoing tonsillectomy- a randomized controlled study - nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087614

Enrollment

Registered

2025-05-26

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: B950- Streptococcus, group A, as the cause of diseases classified elsewhere

Interventions

Intervention1: 10% lignocaine spray: The lignocaine spray will be administered over the tongue, valleculla and the pillars of the tonsil. Control Intervention1: Distilled water spray: The distilled wa

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged between 5-18 years of either sex posted for elective tonsillectomy

Exclusion criteria

Exclusion criteria: Patients with contraindications to lignocaine Patients with history of allergic to local anesthetics. Patients with history of cardiovascular diseases, hypertension.

Design outcomes

Primary

Measure	Time frame
To measure and compare the changes in heart rate in the two group of patients (lignocaine- group L, Distilled water- group N )Timepoint: Baseline post induction post intubation post intubation-3mins, 6mins, 9 mins, 12 mins. Mouth gag insertion Post mouth gag insertion- 2mins, 4 mins, 6 mins, 8 mins, 10 mins Incision Post incision and dissection-15 mins, 30 mins, 45 mins, 60 mins Post extubation	—

Secondary

Measure	Time frame
To measure and compare the blood pressure(systolic, diastolic and MAP) recorded prior to and immediately following the application of the mouth gag, and at predefined intervals till surgery in two groups. To compare the additional narcotic requirements during the surgery in two groups. Any adverse event related to the interventions will be noted.Timepoint: Baseline post induction post intubation post intubation-3mins, 6mins, 9 mins, 12 mins. Mouth gag insertion Post mouth gag insertion- 2mins, 4 mins, 6 mins, 8 mins, 10 mins Incision Post incision and dissection-15 mins, 30 mins, 45 mins, 60 mins Post extubation	—

Measure

Time frame

To measure and compare the blood pressure(systolic, diastolic and MAP) recorded prior to and immediately following the application of the mouth gag, and at predefined intervals till surgery in two groups. To compare the additional narcotic requirements during the surgery in two groups. Any adverse event related to the interventions will be noted.Timepoint: Baseline post induction post intubation post intubation-3mins, 6mins, 9 mins, 12 mins. Mouth gag insertion Post mouth gag insertion- 2mins, 4 mins, 6 mins, 8 mins, 10 mins Incision Post incision and dissection-15 mins, 30 mins, 45 mins, 60 mins Post extubation

—

Countries

India

Contacts

Public ContactPARTHASARATHY S

SBV deemed to be university

painfreepartha@gmail.com9443142582

Outcome results

None listed

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