Regional Nasal Block and Dexmedetomidine in Endoscopic Sinus Surgery

NCT05361642 | Unknown DMC

• 1 other identifier: FMASU MD 60/2021
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drug Use

Outcome Measures

Primary Outcomes (1)

• Optimizing intraoperative surgical field

  Comparison between efficacy of the two techniques in optimizing intraoperative surgical field which will be measured using the average category scale(where grade 0 is defined as no bleeding and grade 5 is defined as severe bleeding, constant suctioning required).

  Up to 6 months

Secondary Outcomes (8)

• Heart rate in beat per minute

  Up to 8 months

• Blood loss in millilitres

  Up to 8 months

• endtidal sevoflurane concentration in MAC%

  Up to 8 months

• phentolamine requirements in milligrams

  Up to 8 months

• Duration of anesthesia in minutes

  Up to 8 months

Study Arms (2)

regional nasal block

ACTIVE COMPARATOR

sphenopalatine ganglion block with general anesthesia

Drug: Bupivacaine HCl 0.5% Injectable Solution

dexmedetomidine

ACTIVE COMPARATOR

use the drug with general anesthesia

Drug: Dexmedetomidine

Interventions

Bupivacaine HCl 0.5% Injectable Solution DRUG

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

Also known as: Lidocaine 2%

regional nasal block

Dexmedetomidine DRUG

using dexmedetomidine with induction of general anesthesia to optimize surgical field

dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Moustafa Rakha

Cairo, 0200, Egypt

RECRUITING

MeSH Terms

Interventions

Bupivacaine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nahed Effat Yossef Salama, Professor

  Ain Shams University

  STUDY CHAIR

Central Study Contacts

Moustafa At Moustafa Hamouda, Ass lecturer

CONTACT

+201061123460; moustafaatef.13b@gmail.com

Rehab Ab Abdelrazik Elsayed, Lecturer

CONTACT

+201110108610; rehab.fattah2002@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: May 5, 2022
• Study Start: February 3, 2022
• Primary Completion: November 5, 2022
• Study Completion: December 5, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year
• Access Criteria: all collected IPD

Locations

EG (1)