Preemptive Chlorepheniramine Maleate Reducing Postoperative Agitation

NCT04293081 | Completed

• 1 other identifier: FMASU R 01/2019
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to identify the role of preoperative chlorepheniramine maleate on alleviating or reducing the severity of postoperative agitation following FESS procedures.

Conditions

Agitated; State, Acute Reaction to Stress

Keywords

chlorpheniramine maleate, Agitation, FESS

Outcome Measures

Primary Outcomes (1)

• reduction of postoperative agitation following FESS procedures using chlorpheniramine maleate

  agitation assessed by Richmond Agitation Sedation Scale (RASS)(0= alert calm, 1=restless, 2 mild agitation, 3= severe agitation, 4= combative)

  Start immediately postextubation (0) minute and every 5 minute for 30 minutes after recovery),

Secondary Outcomes (2)

• pain assessement: visual analogue score

  starting at 30 minutes postoperative then at 2, 6, and 12 hours postoperatively

• The duration of surgery and anesthesia with time needed for extubation

  intraoperative

Study Arms (2)

chlorpheniramine maleate group

ACTIVE COMPARATOR

A total of 45 adult patients undergoing FESS procedure for sinusitis with postoperative nasal packing. Written informed consent will be obtained from all patients before randomization. Patients will be assigned to chlorepheniramine maleate group (A)

Drug: Preemptive chlorepheniramine maleate intravenous injection

placebo group

PLACEBO COMPARATOR

A total of 45 adult patients undergoing FESS procedure for sinusitis with postoperative nasal packing. Written informed consent will be obtained from all patients before randomization. Patients will be assigned to placebo group (A)

Drug: normal saline

Interventions

Preemptive chlorepheniramine maleate intravenous injection DRUG

Participants of group A will receive only one ampoule of 45.5 mg/ 2mL chlorepheniramine maleate diluted in 8 ml isotonic saline intravenous (I.V) prior to induction of general anesthesia by 30 minutes

chlorpheniramine maleate group

normal saline DRUG

participants in group (B) will receive 10 ml isotonic saline (placebo) by the same route as control.

Also known as: normal isotonic saline

placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

AinShams University, Faculty of medicine

Cairo, Abbasia, 11591, Egypt

Location

MeSH Terms

Conditions

Psychomotor Agitation; Stress Disorders, Traumatic, Acute

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• 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

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 3, 2020
• Study Start: January 16, 2019
• Primary Completion: May 31, 2019
• Study Completion: July 30, 2019
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)