Regional Nasal Block and Dexmedetomidine in Endoscopic Sinus Surgery

NCT ID: NCT05361642

Last Updated: 2022-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-03

Study Completion Date

2022-12-05

Brief Summary

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The purpose is to compare the efficacy of combined regional nasal block and general anesthesia versus general anesthesia with dexmedetomidine during endoscopic sinus surgery in optimizing intraoperative surgical field.

Detailed Description

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This study will be done to compare between two different techniques including regional nasal block and dexmedetomidine in optimizing intraoperative surgical field according to average category scale

Conditions

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Drug Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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regional nasal block

sphenopalatine ganglion block with general anesthesia

Group Type ACTIVE_COMPARATOR

Bupivacaine HCl 0.5% Injectable Solution

Intervention Type DRUG

using nasal block including sphenopalatine ganglion block with general anesthesia to optimize surgical field

dexmedetomidine

use the drug with general anesthesia

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

using dexmedetomidine with induction of general anesthesia to optimize surgical field

Interventions

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Bupivacaine HCl 0.5% Injectable Solution

using nasal block including sphenopalatine ganglion block with general anesthesia to optimize surgical field

Intervention Type DRUG

Dexmedetomidine

using dexmedetomidine with induction of general anesthesia to optimize surgical field

Intervention Type DRUG

Other Intervention Names

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Lidocaine 2%

Eligibility Criteria

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Inclusion Criteria

* Patients of ASA I or ASA II physical status.
* Patients with age 18-65 years.

Exclusion Criteria

* Patients with physical status ASA III, IV.
* Known allergic reactions to local anesthetics.
* Patients with history for cerebrovascular or coronary insufficiency.
* Patients with infection at the block site.
* Patients with coagulopathy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nahed Effat Yossef Salama, Professor

Role: STUDY_CHAIR

Ain Shams University

Locations

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Moustafa Rakha

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Moustafa At Moustafa Hamouda, Ass lecturer

Role: CONTACT

+201061123460

Rehab Ab Abdelrazik Elsayed, Lecturer

Role: CONTACT

+201110108610

Facility Contacts

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Moustafa Rakha

Role: primary

01061123460

Other Identifiers

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FMASU MD 60/2021

Identifier Type: -

Identifier Source: org_study_id

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