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

Primary Purpose

Agitation States as Acute Reaction to Gross Stress

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
External nasal nerve block
saline adrenaline
Xylocaine, adrenaline
Sponsored by
Al Jedaani Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Agitation States as Acute Reaction to Gross Stress focused on measuring Nasal surgery, external nasal nerve block, postoperative agitation

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Al Jedaani group of hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group I(control)

Group II(block)

Arm Description

patients allocated for external nasal nerve block with saline adrenaline 1/200,000 (placebo)

'External nasal nerve block by Xylocaine, adrenaline'

Outcomes

Primary Outcome Measures

postoperative agitation
Assessment done using Richmond agitation- sedation scale (RASS)
Quality of recovery
Quality of recovery

Secondary Outcome Measures

dose of fentanyl
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)
morphine dose 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
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
Extubation time
Surgical time
intraoperative
first verbal response time
period from discontinuation of anesthesia 'time zero' to 1st verbal response in minutes
complication of nasal block
including local anesthetic systemic toxicity, vascular injury, intravascular injection of local anesthetic, and local hematoma.

Full Information

First Posted
February 19, 2017
Last Updated
December 23, 2017
Sponsor
Al Jedaani Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03069027
Brief Title
Efficacy of External Nasal Nerve Block in Prevention of Postoperative Agitation Following Nasal Surgeries
Official Title
Efficacy of External Nasal Nerve Block on Postoperative Agitation Following Nasal Surgeries Under General Anesthesia. Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 15, 2016 (Actual)
Primary Completion Date
April 15, 2017 (Actual)
Study Completion Date
July 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al Jedaani Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation States as Acute Reaction to Gross Stress
Keywords
Nasal surgery, external nasal nerve block, postoperative agitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I(control)
Arm Type
Placebo Comparator
Arm Description
patients allocated for external nasal nerve block with saline adrenaline 1/200,000 (placebo)
Arm Title
Group II(block)
Arm Type
Active Comparator
Arm Description
'External nasal nerve block by Xylocaine, adrenaline'
Intervention Type
Procedure
Intervention Name(s)
External nasal nerve block
Intervention Description
Three single (midline injection) and 4 paired (bilateral injection) sites to block the external nasal sensation.
Intervention Type
Drug
Intervention Name(s)
saline adrenaline
Intervention Type
Drug
Intervention Name(s)
Xylocaine, adrenaline
Primary Outcome Measure Information:
Title
postoperative agitation
Description
Assessment done using Richmond agitation- sedation scale (RASS)
Time Frame
Emergence is defined as the time interval from discontinuation of anesthesia to 5 min after extubation.
Title
Quality of recovery
Description
Quality of recovery
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
dose of fentanyl
Description
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)
Time Frame
intraoperative period in minutes
Title
morphine dose in PACU
Description
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
Time Frame
one hour in PACU
Title
Nausea and vomiting in PACU
Description
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
Time Frame
one hour in PACU
Title
Extubation time
Time Frame
Up to 15 after discontinuation of anesthesia
Title
Surgical time
Description
intraoperative
Time Frame
duration of surgery in minutes up to 3 hours
Title
first verbal response time
Description
period from discontinuation of anesthesia 'time zero' to 1st verbal response in minutes
Time Frame
up to 15 minutes
Title
complication of nasal block
Description
including local anesthetic systemic toxicity, vascular injury, intravascular injection of local anesthetic, and local hematoma.
Time Frame
From injection to 24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: History of uncontrolled hypertension, Ischemic or valvular heart disease, Use of MAO inhibitors or adrenergic blocking drugs, Cognitive impairment, Patients taking antipsychotics, Renal insufficiency or liver dysfunction
Facility Information:
Facility Name
Al Jedaani group of hospitals
City
Jeddah
State/Province
Meccah
ZIP/Postal Code
21462/7500
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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