Regional Nasal Block and Dexmedetomidine in Endoscopic Sinus Surgery

Drug Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05361642
• Other study ID #: FMASU MD 60/2021
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2022
• Est. completion date: December 5, 2022

Study information

• Verified date: August 2022
• Source: Ain Shams University
• Contact: Moustafa At Moustafa Hamouda, Ass lecturer
• Phone: +201061123460
• Email: moustafaatef.13b[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 5, 2022
• Est. primary completion date: November 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Use

Intervention

Drug:
• Bupivacaine HCl 0.5% Injectable Solution
using nasal block including sphenopalatine ganglion block with general anesthesia to optimize surgical field
• Dexmedetomidine
using dexmedetomidine with induction of general anesthesia to optimize surgical field

Locations

Country	Name	City	State
Egypt	Moustafa Rakha	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart rate in beat per minute	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
Secondary	Blood loss in millilitres	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
Secondary	endtidal sevoflurane concentration in MAC%	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
Secondary	phentolamine requirements in milligrams	The total dose of additional hypotensive agent (phentolamine) requirements will be measured in milligrams	Up to 8 months
Secondary	Duration of anesthesia in minutes	Duration of anesthesia will be measured in minutes	Up to 8 months
Secondary	Pain assessment with visual analogue scale(VAS)	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
Secondary	Mean blood pressure in mmHg	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
Secondary	Duration of surgery in minutes	Duration of surgery will be measured in minutes	Up to 8 months