Intranasal Injection of Dexmedetomidine and Bupivacaine in Septoplasty Surgeries

Intranasal Bupivacaine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03926663
• Other study ID #: FMBSUREC/05032019/Moselhy
• Status: Recruiting
• Phase: Phase 4
• Start date: July 20, 2019
• Est. completion date: September 2019

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: Mohamed Moselhy, MD
• Phone: +201145504361
• Email: Mosobing[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Intranasal Bupivacaine
• Intranasal Dexmedetomidine
• Septoplasty Surgeries

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine, a potent a-2 adrenoceptor agonist, is approximately 8 times more selective toward the a-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
patients will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) preincisional local infiltration of the nasal mucosa.

Locations

Country	Name	City	State
Egypt	Faculty of medicine,Beni-Suef University	Bani Suwayf

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The precentage of patients that will take rescue drugs as nitroglycerin, propranolol.	the 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.	3 hours