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

Primary Purpose

Hypotensive Anesthesia

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
General anesthesia with fentanyl boluses
Regional block
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypotensive Anesthesia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

GS [General anesthesia]

GR [General anesthesia + regional block]

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hypotensive anesthesia
Measurement of Mean arterial blood pressure
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]

Secondary Outcome Measures

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]

Full Information

First Posted
December 11, 2018
Last Updated
December 14, 2018
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03774693
Brief Title
Regional Block of the Nose for Hypotensive Anaesthesia in Septo-rhinoplasty
Official Title
Efficacy of Regional Block of the Nose in Achieving Hypotensive Anaesthesia in Septo-rhinoplasty Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 28, 2018 (Actual)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotensive Anesthesia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GS [General anesthesia]
Arm Type
Active Comparator
Arm Description
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.
Arm Title
GR [General anesthesia + regional block]
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
General anesthesia with fentanyl boluses
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Regional block
Intervention Description
Patients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block.
Primary Outcome Measure Information:
Title
Hypotensive anesthesia
Description
Measurement of Mean arterial blood pressure
Time Frame
Intraoperative
Title
Requirements of Fentanyl
Description
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]
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Average category scale (ACS)
Description
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]
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
11591
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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