Regional Block of the Nose for Hypotensive Anaesthesia in Septo-rhinoplasty

Hypotensive Anesthesia Clinical Trial

Official title:

Efficacy of Regional Block of the Nose in Achieving Hypotensive Anaesthesia in Septo-rhinoplasty Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03774693
• Other study ID #: FMASU R66/2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 28, 2018
• Est. completion date: March 2019

Study information

• Verified date: December 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Septorhinoplasty is a cosmetic surgery that many people are choosing to undergo. It can be done under general anesthesia, twilight anesthesia or regional anesthesia. Controlled hypotensive anesthesia is required to minimize bruising, swelling, and bleeding that reduces visibility in the operative field and hence satisfactory surgical outcome.

The goal of our study to prove that regional block of the nose provides efficient hypotensive anesthesia

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: March 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status I-II

• Scheduled for elective septo-rhinoplasty surgery

Exclusion Criteria:

• Patients with hypertension or coronary artery disease,

• Patients with renal, hepatic or cerebral insufficiency,

• Patients with coagulopathy or receiving drugs influencing blood coagulation,

• Patients with known sensitivity to any of the study drug

Related Conditions & MeSH terms

• Hypotension
• Hypotensive Anesthesia

Intervention

Other:
• General anesthesia with fentanyl boluses
Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1

Procedure:
• Regional block
Patients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypotensive anesthesia	Measurement of Mean arterial blood pressure	Intraoperative
Primary	Requirements of Fentanyl	Assessment of intraoperative fentanyl doses of [Fentanyl boluses of 0.5 mcg.Kg-1 will be given to maintain mean arterial pressure (MAP) between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1]	Intraoperative
Secondary	Average category scale (ACS)	The surgeon will be asked, at the end of surgery, to assess bleeding in the surgical field using the average category scale 0-5 scale where [0=No bleeding and5=Severe bleeding]	Intraoperative