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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: Al Jedaani Hospital

Current Primary Outcome:

  • 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)
  • Quality of recovery [ Time Frame: 24 hours postoperative ]
    Quality of recovery


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)
  • 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
  • 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
  • Extubation time [ Time Frame: Up to 15 after discontinuation of anesthesia ]
  • Surgical time [ Time Frame: duration of surgery in minutes up to 3 hours ]
    intraoperative
  • first verbal response time [ Time Frame: up to 15 minutes ]
    period from discontinuation of anesthesia 'time zero' to 1st verbal response in 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.


Original Secondary Outcome: Same as current

Information By: Al Jedaani Hospital

Dates:
Date Received: February 19, 2017
Date Started: August 15, 2016
Date Completion: May 1, 2017
Last Updated: March 1, 2017
Last Verified: February 2017