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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774693
Recruitment Status : Active, not recruiting
First Posted : December 13, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Hanan Mahmoud Farag Awad, Ain Shams University

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


Condition or disease Intervention/treatment Phase
Hypotensive Anesthesia Other: General anesthesia with fentanyl boluses Procedure: Regional block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Efficacy of Regional Block of the Nose in Achieving Hypotensive Anaesthesia in Septo-rhinoplasty Surgery
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: GS [General anesthesia]
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
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

Active Comparator: GR [General anesthesia + regional block]

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
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.




Primary Outcome Measures :
  1. Hypotensive anesthesia [ Time Frame: Intraoperative ]
    Measurement of Mean arterial blood pressure

  2. Requirements of Fentanyl [ Time Frame: Intraoperative ]
    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 :
  1. Average category scale (ACS) [ Time Frame: Intraoperative ]
    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]



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774693


Locations
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Egypt
Ain Shams University
Cairo, Egypt, 11591
Sponsors and Collaborators
Ain Shams University
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Responsible Party: Hanan Mahmoud Farag Awad, Assisstant Professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT03774693    
Other Study ID Numbers: FMASU R66/2018
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Fentanyl
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General