Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intranasal Injection of Dexmedetomidine and Bupivacaine in Septoplasty Surgeries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926663
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Marwa Zayed, Cairo University

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 Intervention/treatment Phase
Intranasal Dexmedetomidine Intranasal Bupivacaine Septoplasty Surgeries Drug: Dexmedetomidine Drug: Bupivacaine 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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 20, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other Name: Marcaine

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.

Other Name: Precedex,

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.
Other Name: Marcaine




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926663


Contacts
Layout table for location contacts
Contact: Mohamed Moselhy, MD +201145504361 Mosobing@gmail.com
Contact: Marwa Zayed, MD 01005059706 marwa.zayed@kasralainy.edu.eg

Locations
Layout table for location information
Egypt
Faculty of medicine,Beni-Suef University Recruiting
Banī Suwayf, Egypt, 62511
Contact: Mohamed Moselhy, MD         
Sponsors and Collaborators
Cairo University
Layout table for additonal information
Responsible Party: Marwa Zayed, Lecturer of anesthesia, Cairo University
ClinicalTrials.gov Identifier: NCT03926663    
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dexmedetomidine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action