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Intranasal Injection of Dexmedetomidine and Bupivacaine in Septoplasty Surgeries

Effects of Intranasal Injection of Dexmedetomidine Plus Bupivacaine on Anesthesia & Analgesia in Septoplasty Surgeries

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03926663
Enrollment
40
Registered
2019-04-24
Start date
2019-07-20
Completion date
2019-09-30
Last updated
2019-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intranasal Bupivacaine, Intranasal Dexmedetomidine, Septoplasty Surgeries

Brief summary

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

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

Interventions

DRUGDexmedetomidine

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.

DRUGBupivacaine

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The precentage of patients that will take rescue drugs as nitroglycerin, propranolol.3 hoursthe number of patients that will need rescue drugs: propranolol 1mg will be given then after 15 minutes (with no improvement of the surgical field) nitroglycerin (NTG) infusion will be added in a titrated manner 0.1-0.5 μg/kg/min gradually till the target MAP (±60 mmHg) is reached.

Countries

Egypt

Contacts

Primary ContactMohamed Moselhy, MD
Mosobing@gmail.com+201145504361
Backup ContactMarwa Zayed, MD
marwa.zayed@kasralainy.edu.eg01005059706

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026