Intranasal Injection of Dexmedetomidine and Bupivacaine in Septoplasty Surgeries

NCT ID: NCT03926663

Last Updated: 2019-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-20

Study Completion Date

2019-09-30

Brief Summary

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Pain is particularly common after nasal surgery, especially when bone manipulation and periosteal irritation are involved. Appropriate pain control is an important consideration in the post-surgical management of patients.

Detailed Description

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Multiple researches and clinical observations suggest that pain reduction can be achieved in nasal surgery by using local anesthesia.The combination of local anesthetic infiltration, directly in the surgical field, with general anesthesia provides beneficial analgesic effects by blocking nociceptive pathways, and there by it reduces the need for systemic analgesics.

The use of α-2 Adrenergic receptor (adrenoceptor) agonists in anesthesia were the focus of interest for their sedative, analgesic, and perioperative sympatholytic and cardiovascular stabilizing effects with reduced anesthetic requirements. α-2 agonists, inhibit substance P release in the nociceptive pathway at the level of the dorsal root neuron; in addition, α-2 adrenergic receptors located at nerve endings may have a role in the analgesic effect of the drug by preventing norepinephrine release.

In this study, the combined effects of dexmedetomidine with bupivacaine as local anesthetics vs bupivacaine, will be investigated in septoplasty to determine the need for rescue drugs as propanlol and nitroglycerine, as hypotensive agents,for bloodless surgical field and optimal procedure for pain control

Conditions

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Intranasal Dexmedetomidine Intranasal Bupivacaine Septoplasty Surgeries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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group Bupivacaine

Group B; will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) as preincisional local infiltration of the nasal mucosa of the nasal septum ,injected once before surgical intervention

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

patients will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) preincisional local infiltration of the nasal mucosa.

group Bupivacaine +Dexmedetomidine

group B+D; will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) + 0.2 μg/kg dexmedetomidine preincisional local infiltration of the nasal mucosa of the nasal septum,injected once before surgical intervention.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine, a potent α-2 adrenoceptor agonist, is approximately 8 times more selective toward the α-2 adrenoceptors than clonidine.

Patients will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) + 0.2 μg/kg dexmedetomidine preincisional local infiltration of the nasal mucosa.

Bupivacaine

Intervention Type DRUG

patients will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) preincisional local infiltration of the nasal mucosa.

Interventions

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Dexmedetomidine

Dexmedetomidine, a potent α-2 adrenoceptor agonist, is approximately 8 times more selective toward the α-2 adrenoceptors than clonidine.

Patients will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) + 0.2 μg/kg dexmedetomidine preincisional local infiltration of the nasal mucosa.

Intervention Type DRUG

Bupivacaine

patients will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) preincisional local infiltration of the nasal mucosa.

Intervention Type DRUG

Other Intervention Names

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Precedex, Marcaine

Eligibility Criteria

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Inclusion Criteria

* Patients aged from 18- 60 years
* ASA physical status I
* Undergoing septoplasty

Exclusion Criteria

* Patients with cardiovascular disease (congestive heart failure, coronary artery disease, hypertension.
* History of renal or hepatic insufficiency
* Endocrinal Diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Zayed

Lecturer of anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of medicine,Beni-Suef University

Banī Suwayf, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed Moselhy, MD

Role: CONTACT

+201145504361

Marwa Zayed, MD

Role: CONTACT

01005059706

Facility Contacts

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Mohamed Moselhy, MD

Role: primary

Other Identifiers

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FMBSUREC/05032019/Moselhy

Identifier Type: -

Identifier Source: org_study_id

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