Efficacy of External Nasal Nerve Block in Prevention of Postoperative Agitation Following Nasal Surgeries

Not Applicable

Completed

• Conditions: Agitation States as Acute Reaction to Gross Stress
• Interventions: Procedure: External nasal nerve block; Drug: Xylocaine, adrenaline; Drug: saline adrenaline

• Registration Number: NCT03069027
• Lead Sponsor: Al Jedaani Hospital

Brief Summary

Emergence agitation following general anaesthesia may lead to serious complications like self-extubation or removal of catheters, which can lead to hypoxia, aspiration pneumonia, bleeding or reoperation. Nose surgery is associated with a higher incidence of emergence agitation. The investigators planned to evaluate the efficacy of external nasal nerve block in prevention of postoperative agitation following external nasal surgeries under general anesthesia(GA).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-15
• Study First Submitted: 2017-02-19
• Study First Submitted QC: 2017-03-01
• Study First Posted: 2017-03-03
• Primary Completion: 2017-04-15
• Study Completion: 2017-07-01
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-23
• Last Update Posted: 2017-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 110 adult patients of ASA physical status I and II,
• Age 20-60 years,
• Scheduled for elective external nasal surgeries in which nasal packing on each side was used postoperatively for 24 hours.

Exclusion Criteria

1. History of uncontrolled hypertension,
2. Ischemic or valvular heart disease,
3. Use of MAO inhibitors or adrenergic blocking drugs,
4. Cognitive impairment,
5. Patients taking antipsychotics,
6. Renal insufficiency or liver dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II(block)	Xylocaine, adrenaline	'External nasal nerve block by Xylocaine, adrenaline'
Group I(control)	saline adrenaline	patients allocated for external nasal nerve block with saline adrenaline 1/200,000 (placebo)
Group II(block)	External nasal nerve block	'External nasal nerve block by Xylocaine, adrenaline'
Group I(control)	External nasal nerve block	patients allocated for external nasal nerve block with saline adrenaline 1/200,000 (placebo)

Primary Outcome Measures

Name	Time	Method
postoperative agitation	Emergence is defined as the time interval from discontinuation of anesthesia to 5 min after extubation.	Assessment done using Richmond agitation- sedation scale (RASS)
Quality of recovery	24 hours postoperative	Quality of recovery

Secondary Outcome Measures

Name	Time	Method
Extubation time	Up to 15 after discontinuation of anesthesia
Surgical time	duration of surgery in minutes up to 3 hours	intraoperative
first verbal response time	up to 15 minutes	period from discontinuation of anesthesia 'time zero' to 1st verbal response in minutes
dose of fentanyl	intraoperative period in minutes	Fentanyl boluses were given in response to changes in hemodynamics (more than 15% increases in MAP and HR than the baseline values taken after induction by 5 minutes)
complication of nasal block	From injection to 24 hours postoperative	including local anesthetic systemic toxicity, vascular injury, intravascular injection of local anesthetic, and local hematoma.
morphine dose in PACU	one hour in PACU	equivalent morphine dose in PACU (calculated using opioid:morphine equivalents of 100 µg i.v. fentanyl to 10 mg i.v. morphine; 75- 100 mg IV pethidine to 10 mg i.v. morphine
Nausea and vomiting in PACU	one hour in PACU	Four-point nausea and vomiting scale (0=no nausea; 1=mild nausea; 2=severe nausea requiring antiemetics; and 3=retching, vomiting, or both) was also evaluated

Trial Locations

Locations (1)

Al Jedaani group of hospitals; 🇸🇦 Jeddah, Meccah, Saudi Arabia