A Comparative Study to Measure the Effect of Nebulized Dexmedetomidine

NCT05158348 | Unknown Phase 3 DMC

• 1 other identifier: MS-394-2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A comparative study to measure the effect of nebulized dexmedetomidine - lidocaine for controlling postoperative pain after tonsillectomy in adults.

Conditions

Dexmedetomidine; Lidocaine; Tonsillectomy

Keywords

Post tonsillectomy; Pain; Dexmedetomidine; Lidocaine

Outcome Measures

Primary Outcomes (1)

• Postoperative pain 4 hours after tonsillectomy measured by visual analogue score

  4 hours postoperative

Secondary Outcomes (1)

• Postoperative nausea and vomiting following tonsillectomy operation after1 hour , 2 hours and after 4 hours

  4 hours postoperative

Study Arms (3)

Group A

ACTIVE COMPARATOR

receive intra-operative local infiltration of saline in tonsillar bed and post-operative nebulised dexametomidine and lidocaine.

Drug: Dexmedetomidine Hydrochloride

Group B

ACTIVE COMPARATOR

receive intra-operative local infiltration of saline and post-operative will receive nebulised lidocaine

Drug: Nebulized lidocaine

Group C

ACTIVE COMPARATOR

receive intra-operative local infiltration of lidocaine and post-operative nebulised saline.

Drug: Local infiltration of lidocaine

Interventions

Dexmedetomidine Hydrochloride DRUG

Group A will receive post-operative nebulised dexametomidine and lidocaine.

Group A

Nebulized lidocaine DRUG

Group B will receive post-operative will receive nebulised lidocaine

Group B

Local infiltration of lidocaine DRUG

group C will receive intra-operative local infiltration of lidocaine

Group C

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of either sex, aged between 18-30 years old, ASA physical status I, II undergoing tonsillectomy.

You may not qualify if:

• Patients were excluded if they had clinically important coronary atherosclerotic heart disease, a history of stroke or transient ischemic attack, Sinus bradycardia or heart block, coagulopathy, peritonsillar abscess, any infection at the site of injection, Known allergy to the study drugs (lidocaine, dexmedetomidine).

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo university hospitals

Cairo, 11559, Egypt

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dina Mohamed

  Egypt Cairo university hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dina Mohamed

CONTACT

01005249134; dinamahmoud@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, lecturer of anesthesia and ICU and pain management

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 15, 2021
• Study Start: November 5, 2021
• Primary Completion: April 10, 2022
• Study Completion: April 15, 2022
• Last Updated: December 15, 2021

Record last verified: 2021-12

Locations

EG (1)