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Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Nasal Sephoplasty Surgery.

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ClinicalTrials.gov Identifier: NCT01964586
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : October 17, 2013
Sponsor:
Information provided by (Responsible Party):
Adnan Bayram, TC Erciyes University

Study Description
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Brief Summary:
It is very important to decrease the bleeding during nasal septoplasty in order to increase the visibility of the surgical site. Our primary goal was to investigate the effects of dexmedetomidine and lidocaine plus adrenaline on visibility of surgical site and postoperative analgesic consumption.

Condition or disease Intervention/treatment Phase
Surgery Pain Drug: Dexmedetomidine Drug: Lidocaine Drug: Adrenaline Phase 4

Detailed Description:
Nasal septoplasty is a surgery procedure which needs to have decrease the bleeding during the surgery for the visibility of surgical site.And postoperative pain is very usual after the surgery, so an effective postoperative analgesia procedure reduces the complications and helps to be discharged earlier from the hospital. An alpha 2 agonist Dexmedetomidine has an analgesic effect and vasoconstructive effect on the periferal blood vessels. Our hypothesis was dexmedetomidine makes a better surgecal conditions during the surgery and reduce the postoperative analgesic consumption. We administered the infiltrated dexmedetomidine or lidocaine plus adrenaline to the both side of the nasal septum 10 minutes before the surgery. Bleeding scores (Fromm and Boezaart Bleeding Scores) were recorded during the surgery. And postoperative analgesic consumptions were recorded in first 24 hours after the surgery.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 4 Study of Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Surgical Conditions and Postoperative Analgesic Consumption in Nasal Sephoplasty Surgery.
Study Start Date : March 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : October 2013

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Lidocaine plus Adrenaline
Lidocaine and adrenaline diluted to 10 ml with normal salin and infiltrated to both side of the nasal septum before 10 minutes from the surgery.
 Drug: Lidocaine
10 ml 2% lidocaine was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.
Other Name: Jetokain %2

Drug: Adrenaline
12.5 mcg/ml 10 ml adrenaline was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.
Other Names:
  • Adrenalin
  • Epinefrin
Active Comparator: Dexmedetomidine
2 mcg/kg dexmedetomidine diluted to 10 ml with normal salin and infiltrated to both side of the nasal septum before 10 minutes the surgery.
 Drug: Dexmedetomidine
2 mcg/kg dexmedetomidine was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.
Other Name: Precedex


Outcome Measures
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Primary Outcome Measures :
  1. surgical conditions [ Time Frame: during the surgery ]
    Bleeding scores were recorded during the surgery


Secondary Outcome Measures :
  1. Analgesic Consumption [ Time Frame: Up to 24 hours ]
    Analgesic consumption were recorded.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for the nasal septoplasty surgery
  • ASA 1-2 patients
  • 18-60 yo patients

Exclusion Criteria:

  • Pregnant patients
  • ASA 3-4 patients
  • Under 18 yo childrens
Contacts and Locations
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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): NCT01964586


Sponsors and Collaborators
TC Erciyes University
Investigators
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Principal Investigator: Adnan Bayram, MD TC Erciyes University
More Information
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Responsible Party: Adnan Bayram, Asst Prof, TC Erciyes University
ClinicalTrials.gov Identifier: NCT01964586    
Other Study ID Numbers: 2013/167
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: October 17, 2013
Last Verified: October 2013
Keywords provided by Adnan Bayram, TC Erciyes University:
Septoplasty, Dexmedetomidine, Surgical Conditions
Additional relevant MeSH terms:
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Lidocaine
Epinephrine
Racepinephrine
Dexmedetomidine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics