Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation | NCT03427502 | Trialant

CompletedInterventionalNot ApplicableUpdated Sep 11, 2020

Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation

Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation Following Nasal Surgeries With Nasal Packs Under General Anesthesia: A Double Blind Randomized Control Trial

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT03427502
Lead Sponsor: Lumbini Medical CollegeOTHER
Overall Status: Completed
Study Type: Interventional
Phase: Not Applicable
Enrollment: 100Actual
Last Update Posted: Sep 11, 2020Actual
Start Date: Jun 1, 2018Actual
Primary Completion Date: Dec 30, 2019Actual
Completion Date: Feb 28, 2020Actual

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation Following Nasal Surgeries With Nasal Packs Under General Anesthesia: A Double Blind Randomized Control Trial
Brief Summary: Postoperative agitation is an important complication of general anesthesia, moreover, it has been found with high incidence in ear, nose, throat (ENT) surgeries. We aim to study whether anterior ethmoidal nerve block will be successful in reducing postoperative agitation in those patients. Study population will be randomized into two groups, treatment and control group. Anterior ethmoidal nerve block will be done in treatment group and postoperative agitation compared between these two groups. Agitation score will be scored with Riker Sedation-Agitation Scale (SAS).

Ho: Occurrence of post-operative agitation in patients undergoing nasal surgery with nasal pack under general anesthesia is equal in those with ethmoidal nerve block as compared to those without the block.

Ha: Occurrence of post-operative agitation in patients undergoing nasal surgery with nasal pack under general anesthesia is not equal in those with ethmoidal nerve block as compared to those without the block.

Conditions

The medical conditions and diseases this study investigates.

Postoperative Agitation: Impaired Awareness, Abnormal Cognitive Function, Confusion, and Verbal and Physical Agitation During Recovery From General Anesthesia
Deviated Nasal Septum
Chronic Rhinosinusitis (Diagnosis)

Interventions

The treatments and procedures being evaluated in this study.

Bupivacaine-epinephrine
normal saline

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Patients undergoing nasal surgery

Under General Anesthesia

With nasal packs

Exclusion Criteria:

Do not consent to the study.

History of allergy to lignocaine or bupivacaine

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts

The people to reach with questions about this study or how to join it.

No central contacts

There are no central contacts for this study.

Locations

Where the study is run and whether each site is currently recruiting.

Lumbini Medical College

Tānsen, Palpa 32500, Nepal

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Lumbini Medical CollegeOTHER

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