Regional Nasal Block and Dexmedetomidine in Endoscopic Sinus Surgery

August 31, 2022 updated by: Ain Shams University

Comparison Between Combined Regional Nasal Block and General Anesthesia Versus General Anesthesia With Dexmedetomidine During Endoscopic Sinus Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: regional nasal block
sphenopalatine ganglion block with general anesthesia
Drug: Bupivacaine HCl 0.5% Injectable Solution
using nasal block including sphenopalatine ganglion block with general anesthesia to optimize surgical field
Other Names:
  • Lidocaine 2%
Active Comparator: dexmedetomidine
use the drug with general anesthesia
Drug: Dexmedetomidine
using dexmedetomidine with induction of general anesthesia to optimize surgical field

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimizing intraoperative surgical field
Time Frame: Up to 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate in beat per minute
Time Frame: Up to 8 months
The heart rate will be measured in (beat/minute) at the commencement of surgery and at each assessment of the surgical field. The average mean values during the surgical procedures will be calculated in each group.
Up to 8 months
Blood loss in millilitres
Time Frame: Up to 8 months
Blood loss will be measured in millilitres as that collected in the suction apparatus and by weight of the nasal swabs.
Up to 8 months
endtidal sevoflurane concentration in MAC%
Time Frame: Up to 8 months
Endtidal sevoflurane concentration will be used as an indicator of inhaled anaesthetic dose. Mean end-tidal sevoflurane concentration will be calculated for each patient as the average of all concentrations recorded will be measured in MAC%
Up to 8 months
phentolamine requirements in milligrams
Time Frame: Up to 8 months
The total dose of additional hypotensive agent (phentolamine) requirements will be measured in milligrams
Up to 8 months
Duration of anesthesia in minutes
Time Frame: Up to 8 months
Duration of anesthesia will be measured in minutes
Up to 8 months
Pain assessment with visual analogue scale(VAS)
Time Frame: Up to 8 months
Pain intensity will be measured with a 10-cm visual analogue scale (where 0 is defined as no pain at all and 10 as the worst possible pain) at 2, 6 and 12 hours postoperatively.
Up to 8 months
Mean blood pressure in mmHg
Time Frame: Up to 8 months
The mean blood pressure will be measured in mmHg at the commencement of surgery and at each assessment of the surgical field. The average mean values during the surgical procedures will be calculated in each group.
Up to 8 months
Duration of surgery in minutes
Time Frame: Up to 8 months
Duration of surgery will be measured in minutes
Up to 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Nahed Effat Yossef Salama, Professor, Ain shams university hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2022

Primary Completion (Anticipated)

November 5, 2022

Study Completion (Anticipated)

December 5, 2022

Study Registration Dates

First Submitted

February 5, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (Actual)

May 5, 2022

Study Record Updates

Last Update Posted (Actual)

September 2, 2022

Last Update Submitted That Met QC Criteria

August 31, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD 60/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

comparison between the two techniques in optimizing surgical field

IPD Sharing Time Frame

1 year

IPD Sharing Access Criteria

all collected IPD

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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