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

December 23, 2017 updated by: Dr. Mohamed Ibrahim, Al Jedaani Hospital

Efficacy of External Nasal Nerve Block on Postoperative Agitation Following Nasal Surgeries Under General Anesthesia. Randomized, Controlled Trial

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Meccah
      • Jeddah, Meccah, Saudi Arabia, 21462/7500
        • Al Jedaani group of hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Group I(control)
patients allocated for external nasal nerve block with saline adrenaline 1/200,000 (placebo)
Procedure: External nasal nerve block
Three single (midline injection) and 4 paired (bilateral injection) sites to block the external nasal sensation.
Drug: saline adrenaline
Active Comparator: Group II(block)
'External nasal nerve block by Xylocaine, adrenaline'
Procedure: External nasal nerve block
Three single (midline injection) and 4 paired (bilateral injection) sites to block the external nasal sensation.
Drug: Xylocaine, adrenaline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
postoperative agitation
Time Frame: Emergence is defined as the time interval from discontinuation of anesthesia to 5 min after extubation.
Assessment done using Richmond agitation- sedation scale (RASS)
Emergence is defined as the time interval from discontinuation of anesthesia to 5 min after extubation.
Quality of recovery
Time Frame: 24 hours postoperative
Quality of recovery
24 hours postoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
dose of fentanyl
Time Frame: 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)
intraoperative period in minutes
morphine dose in PACU
Time Frame: 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
one hour in PACU
Nausea and vomiting in PACU
Time Frame: 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
one hour in PACU
Extubation time
Time Frame: Up to 15 after discontinuation of anesthesia
Up to 15 after discontinuation of anesthesia
Surgical time
Time Frame: duration of surgery in minutes up to 3 hours
intraoperative
duration of surgery in minutes up to 3 hours
first verbal response time
Time Frame: up to 15 minutes
period from discontinuation of anesthesia 'time zero' to 1st verbal response in minutes
up to 15 minutes
complication of nasal block
Time Frame: From injection to 24 hours postoperative
including local anesthetic systemic toxicity, vascular injury, intravascular injection of local anesthetic, and local hematoma.
From injection to 24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Al Jedaani Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3-2-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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