Agitation States as Acute Reaction to Gross Stress Clinical Trial
Official title:
Efficacy of External Nasal Nerve Block on Postoperative Agitation Following Nasal Surgeries Under General Anesthesia. Randomized, Controlled Trial
| Verified date | December 2017 |
| Source | Al Jedaani Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | July 1, 2017 |
| Est. primary completion date | April 15, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 60 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Saudi Arabia | Al Jedaani group of hospitals | Jeddah | Meccah |
| Lead Sponsor | Collaborator |
|---|---|
| Al Jedaani Hospital |
Saudi Arabia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | postoperative agitation | Assessment done using Richmond agitation- sedation scale (RASS) | Emergence is defined as the time interval from discontinuation of anesthesia to 5 min after extubation. | |
| Primary | Quality of recovery | Quality of recovery | 24 hours postoperative | |
| Secondary | 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) | intraoperative period in minutes | |
| Secondary | 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 | one hour in PACU | |
| Secondary | 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 | one hour in PACU | |
| Secondary | Extubation time | Up to 15 after discontinuation of anesthesia | ||
| Secondary | Surgical time | intraoperative | duration of surgery in minutes up to 3 hours | |
| Secondary | first verbal response time | period from discontinuation of anesthesia 'time zero' to 1st verbal response in minutes | up to 15 minutes | |
| Secondary | complication of nasal block | including local anesthetic systemic toxicity, vascular injury, intravascular injection of local anesthetic, and local hematoma. | From injection to 24 hours postoperative |