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

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Keywords

Abstract

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).

Dates

Last Verified:	11/30/2017
First Submitted:	02/18/2017
Estimated Enrollment Submitted:	02/28/2017
First Posted:	03/02/2017
Last Update Submitted:	12/22/2017
Last Update Posted:	12/26/2017
Actual Study Start Date:	08/14/2016
Estimated Primary Completion Date:	04/14/2017
Estimated Study Completion Date:	06/30/2017

Condition or disease

Agitation States as Acute Reaction to Gross Stress

Intervention/treatment

Procedure: External nasal nerve block

Drug: Group I(control)

Drug: Group II(block)

Phase

Arm Groups

Arm	Intervention/treatment
Placebo Comparator: Group I(control) patients allocated for external nasal nerve block with saline adrenaline 1/200,000 (placebo)	Drug: Group I(control)
Active Comparator: Group II(block) 'External nasal nerve block by Xylocaine, adrenaline'	Drug: Group II(block)

Eligibility Criteria

Ages Eligible for Study	20 Years To 20 Years
Sexes Eligible for Study	All
Accepts Healthy Volunteers	Yes
Criteria	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

Outcome

Primary Outcome Measures

1. 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)

2. Quality of recovery [24 hours postoperative]

Quality of recovery

Secondary Outcome Measures

1. 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)

2. 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

3. 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

4. Extubation time [Up to 15 after discontinuation of anesthesia]

5. Surgical time [duration of surgery in minutes up to 3 hours]

intraoperative

6. first verbal response time [up to 15 minutes]

period from discontinuation of anesthesia 'time zero' to 1st verbal response in minutes

7. 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.

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

Keywords

pneumonia

hypoxia

hemorrhage

emergence delirium