Regional Nasal Block and Dexmedetomidine in Endoscopic Sinus Surgery

Not Applicable

• Conditions: Drug Use
• Interventions: Drug: Bupivacaine HCl 0.5% Injectable Solution; Drug: Dexmedetomidine

• Registration Number: NCT05361642
• Lead Sponsor: Ain Shams University

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.

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 Timeline

• Study Start: 2022-02-03
• Study First Submitted: 2022-02-05
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-05
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-31
• Last Update Posted: 2022-09-02
• Primary Completion: 2022-11-05
• Study Completion: 2022-12-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
regional nasal block	Bupivacaine HCl 0.5% Injectable Solution	sphenopalatine ganglion block with general anesthesia
dexmedetomidine	Dexmedetomidine	use the drug with general anesthesia

Primary Outcome Measures

Name	Time	Method
Optimizing intraoperative surgical field	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Moustafa Rakha; 🇪🇬 Cairo, Egypt