Regional Nasal Block and Dexmedetomidine in Endoscopic Sinus Surgery

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05361642

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Drug Use	Drug: Bupivacaine HCl 0.5% Injectable Solution Drug: Dexmedetomidine	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 3, 2022

Anticipated Primary Completion Date :

May 5, 2022

Anticipated Study Completion Date :

Oct 5, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
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.
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%
phentolamine requirements in milligrams [Up to 8 months]
The total dose of additional hypotensive agent (phentolamine) requirements will be measured in milligrams
Duration of anesthesia in minutes [Up to 8 months]
Duration of anesthesia will be measured in minutes
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.
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 surgery in minutes [Up to 8 months]
Duration of surgery will be measured in minutes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moustafa Rakha	Cairo		Egypt	0200

Sponsors and Collaborators

Ain Shams University

Investigators

Study Chair: Nahed Effat Yossef Salama, Professor, Ain Shams University hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ain Shams University

ClinicalTrials.gov Identifier:

NCT05361642

Other Study ID Numbers:

FMASU MD 60/2021

First Posted:

May 5, 2022

Last Update Posted:

May 5, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Lidocaine

Dexmedetomidine

Bupivacaine

Study Results

No Results Posted as of May 5, 2022