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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Intranasal Injection of Dexmedetomidine and Bupivacaine in Septoplasty Surgeries

Clinicaltrials.gov identifier NCT03926663

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted August 1, 2019

Study Description

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.

  • Condition or Disease:Intranasal Dexmedetomidine
    Intranasal Bupivacaine
    Septoplasty Surgeries
  • Intervention/Treatment: Drug: Dexmedetomidine
    Drug: Bupivacaine
  • Phase: Phase 4
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

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 40 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Supportive Care
  • Official Title: Effects of Intranasal Injection of Dexmedetomidine Plus Bupivacaine on Anesthesia & Analgesia in Septoplasty Surgeries
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: September 2019
  • Estimated Study Completion Date: September 2019
Arms and interventions
Arm Intervention/treatment
Active Comparator: 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.
Drug: 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.

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.
Experimental: 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
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.
Outcome Measures
  • Primary Outcome Measures: 1. The precentage of patients that will take rescue drugs as nitroglycerin, propranolol. [ Time Frame: 3 hours ]
    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.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 60 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts

Contact: Mohamed Moselhy, MD +201145504361 Mosobing@gmail.com

Contact: Marwa Zayed, MD 01005059706 marwa.zayed@kasralainy.edu.eg

Locations

Egypt
Faculty of medicine,Beni-Suef University
Banī Suwayf

Sponsors and Collaborators

Cairo University

More Information
  • Responsible Party: Cairo University
  • ClinicalTrials.gov Identifier: NCT03926663 History of Changes
  • Other Study ID Numbers: FMBSUREC/05032019/Moselhy
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: August 1, 2019
  • Last Verified: July 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No