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Completed

NCT Number: NCT03069027

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

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).

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Key information

Conditions

Agitation States as Acute Reaction to Gross Stress

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Jedaani group of hospitals

Jeddah, Meccah, 21462/7500, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External nasal nerve block

Procedure

Three single (midline injection) and 4 paired (bilateral injection) sites to block the external nasal sensation.

saline adrenaline

Drug

Xylocaine, adrenaline

Drug

Primary outcomes

  1. 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)

  2. Quality of recovery

    Time frame: 24 hours postoperative

    Quality of recovery

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. Extubation time

    Time frame: Up to 15 after discontinuation of anesthesia

  5. Surgical time

    Time frame: duration of surgery in minutes up to 3 hours

    intraoperative

  6. first verbal response time

    Time frame: up to 15 minutes

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

  7. 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.

Sponsors and collaborators

Lead sponsor

Al Jedaani Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 3, 2017
Registry last updated
Dec 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.