Intranasal Injection of Dexmedetomidine and Bupivacaine in Septoplasty Surgeries
Effects of Intranasal Injection of Dexmedetomidine Plus Bupivacaine on Anesthesia & Analgesia in Septoplasty Surgeries
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2019
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2019
CompletedFirst Posted
Study publicly available on registry
April 24, 2019
CompletedStudy Start
First participant enrolled
July 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedAugust 1, 2019
July 1, 2019
1 month
April 22, 2019
July 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
group Bupivacaine
EXPERIMENTALGroup 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 Bupivacaine +Dexmedetomidine
ACTIVE COMPARATORgroup 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.
Interventions
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.
patients will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) preincisional local infiltration of the nasal mucosa.
Eligibility Criteria
You may qualify if:
- Patients aged from 18- 60 years
- ASA physical status I
- Undergoing septoplasty
You may not qualify if:
- Patients with cardiovascular disease (congestive heart failure, coronary artery disease, hypertension.
- History of renal or hepatic insufficiency
- Endocrinal Diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of medicine,Beni-Suef University
Banī Suwayf, 62511, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of anesthesia
Study Record Dates
First Submitted
April 22, 2019
First Posted
April 24, 2019
Study Start
July 20, 2019
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
August 1, 2019
Record last verified: 2019-07