Analgesic Effect of Intranasal Versus Intravenous Dexmedetomidine in FESS

Sponsor

Al-Azhar University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05604599

Collaborator

(none)

Enrollment

Location

Arms

2.7

Anticipated Duration (Months)

22.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Intranasal dexmedetomidine provided good pharmacokinetic profile. However, intravenous dexmedetomidine have been used in functional endoscopic sinus surgery for several outcomes, there is lack in studies that had compared the efficacy of intravenous and Intranasal Dexmedetomidine for improving quality of the operative field in functional endoscopic sinus surgery.

Therefore, we established this randomized study to compare intranasal dexmedetomidine with intravenous dexmedetomidine improving quality of the operative field in functional endoscopic sinus surgery.

Condition or Disease	Intervention/Treatment	Phase
Functional Endoscopic Sinus Surgery Premedication Analgesia	Drug: Intranasal dexmedetomidine Drug: Intravenous dexmedetomidine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Intranasal Premedication With Dexmedetomidine Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia During Functional Endoscopic Sinus Surgery in Adults: A Randomized Triple-Blind Trial

Actual Study Start Date :

Nov 10, 2022

Anticipated Primary Completion Date :

Jan 30, 2023

Anticipated Study Completion Date :

Jan 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intranasal dexmedetomidine group 30 patients will receive 1µg/kg dexmedetomidine diluted in 10ml 0.9% saline intranasally preoperative administered to each naris as drops 45 -60 min before the operation +infusion saline.	Drug: Intranasal dexmedetomidine 45 -60 min before the operation, patients will receive dose of dexmedetomidine 1microgram/kg diluted in 10ml 0.9% saline administered to each naris as drops + infusion saline Other Names: Propofol 2 mg/kg fentanyl 1 µg/kg Cis-atracurium 0.15mg / kg Isoflurane 1-1.5% in 50% oxygen
Active Comparator: Intravenous dexmedetomidine group 30 patients will receive loading dose of dexmedetomidine 1 µg/kg diluted in 10ml 0.9% saline infused over 45- 60 min before induction of anesthesia, followed by continuous infusion of 0.4 µg/kg/h + intranasal saline.	Drug: Intravenous dexmedetomidine patients will receive loading dose of dexmedetomidine 1 µg/kg diluted in 10ml 0.9% saline infused over 45- 60 min before induction of anesthesia, followed by continuous infusion of (0.4 µ g/kg/h) + intranasal saline. Other Names: Propofol 2 mg/kg,, fentanyl 1 µg/kg , Cis-atracurium 0.15mg / kg and Isoflurane 1-1.5% in 50% oxygen

Arm

Intervention/Treatment

Active Comparator: Intranasal dexmedetomidine group

30 patients will receive 1µg/kg dexmedetomidine diluted in 10ml 0.9% saline intranasally preoperative administered to each naris as drops 45 -60 min before the operation +infusion saline.

Drug: Intranasal dexmedetomidine

45 -60 min before the operation, patients will receive dose of dexmedetomidine 1microgram/kg diluted in 10ml 0.9% saline administered to each naris as drops + infusion saline

Other Names:

Propofol 2 mg/kg

fentanyl 1 µg/kg

Cis-atracurium 0.15mg / kg

Isoflurane 1-1.5% in 50% oxygen

Active Comparator: Intravenous dexmedetomidine group

30 patients will receive loading dose of dexmedetomidine 1 µg/kg diluted in 10ml 0.9% saline infused over 45- 60 min before induction of anesthesia, followed by continuous infusion of 0.4 µg/kg/h + intranasal saline.

Drug: Intravenous dexmedetomidine

patients will receive loading dose of dexmedetomidine 1 µg/kg diluted in 10ml 0.9% saline infused over 45- 60 min before induction of anesthesia, followed by continuous infusion of (0.4 µ g/kg/h) + intranasal saline.

Other Names:

Propofol 2 mg/kg,, fentanyl 1 µg/kg , Cis-atracurium 0.15mg / kg and Isoflurane 1-1.5% in 50% oxygen

Outcome Measures

Primary Outcome Measures

Improving quality of the operative field. [during surgery (intraoperatively) 2 hours]
Quality of intraoperative surgical field during functional endoscopic sinus surgery will be evaluated by the surgeons by rating the amount of bleeding according to a 6-point scale by Formmer's scores of surgical field quality (0= no bleeding; 1= bleeding, so mild it was not even a surgical nuisance; 2= moderate bleeding, a nuisance but without interference; 3= moderate bleeding that moderately compromised surgical; 4= bleeding, heavy but controllable, that significantly interfered; 5= massive uncontrollable bleeding.

Secondary Outcome Measures

Hemodynamics(Heart rate (bpm)) [2 hours]
Heart rate (bpm), at base line, 5minute, 10 minute , 30 minute, 45 minute, 60 minute after patient received intranasal and after infusion of loading dose of dexmedetomidine , 5, 15, 30, 45, 60 minutes after induction of anesthesia, at end of surgery and 30 minute after recovery.
Hemodynamics(Mean arterial blood pressure mm Hg)) [2 hours]
Mean arterial blood pressure mm Hg) at base line, 5minute, 10 minute , 30 minute, 45 minute, 60 minute after patient received intranasal and after infusion of loading dose of dexmedetomidine , 5, 15, 30, 45, 60 minutes after induction of anesthesia, at end of surgery and 30 minute after recovery.
Pain score [First 24 hours postoperatively]
Pain measured with VAS: (visual analogue scale) will be assessed in post anesthesia care unit, 1, 2, 4, 6, 8, 12, 18, and 24hours postoperative. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). patients are asked to rate their current level of pain by placing a mark on the line.
Adverse events [24 postoperatively]
Adverse events will be recorded such as nausea, vomiting, hypotension and bradycardia.
hemostatic stuffing [24 hours postoperatively]
The degree of adverse reactions of hemostatic stuffing after functional endoscopic sinus surgery will be also evaluated (1=no swelling, can tolerate; 2= swelling, can barely tolerate; 3= swelling, cannot tolerate).

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients older than 21 years of age.
Both genders.
American Society of Anesthesiologists (ASA) physical status classification I - III who underwent functional endoscopic sinus surgery.

Exclusion Criteria:

Patients with a body mass index > 30 kg/m2
Existing or recent significant disease.
Contraindications to the use of dexmedetomidine.
History or presence of a significant disease.
Significant cardiovascular disease risk factors.
Significant coronary artery disease.
Any known genetic predisposition.
History of any kind of drug allergy.
Drug abuse.
Psychological or other emotional problems.
Special diet or lifestyle.
Clinically significant abnormal findings in physical examination, electrocardiographic (ECG) or laboratory screening.
Known systemic disease requiring the use of anticoagulants.
Any nasal disorders that may hinder nasal administration of the drugs as repeated nasal bleeding or nasal tumors.
Patients with a history of previous functional endoscopic sinus surgery.