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

NCT03774693 | Unknown

• 1 other identifier: FMASU R66/2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hypotensive Anesthesia

Outcome Measures

Primary Outcomes (2)

• Hypotensive anesthesia

  Measurement of Mean arterial blood pressure

  Intraoperative

• 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 Outcomes (1)

• Average category scale (ACS)

  Intraoperative

Study Arms (2)

GS [General anesthesia]

ACTIVE COMPARATOR

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.

Other: General anesthesia with fentanyl boluses

GR [General anesthesia + regional block]

ACTIVE COMPARATOR

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. Also patients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block. Fentanyl boluses of 0.5 mcg.Kg-1 will be given when needed to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1.

Other: General anesthesia with fentanyl boluses; Procedure: Regional block

Interventions

General anesthesia with fentanyl boluses OTHER

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

GR [General anesthesia + regional block]; GS [General anesthesia]

Regional block PROCEDURE

Patients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block.

GR [General anesthesia + regional block]

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-II
• Scheduled for elective septo-rhinoplasty surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

Location

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 13, 2018
• Study Start: November 28, 2018
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2019
• Last Updated: December 17, 2018

Record last verified: 2018-12

Locations

EG (1)