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

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

Tracking Information

• First Submitted Date: October 15, 2013
• First Posted Date: October 17, 2013
• Last Update Posted Date: October 17, 2013
• Study Start Date: March 2013
• Actual Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 15, 2013)

surgical conditions [ Time Frame: during the surgery ]

Bleeding scores were recorded during the surgery

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 15, 2013)

Analgesic Consumption [ Time Frame: Up to 24 hours ]

Analgesic consumption were recorded.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Nasal Sephoplasty Surgery.
• 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.
• 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.
• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Surgery
• Pain

Intervention

• 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
• 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

Study Arms

• 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.
  Interventions:

  • Drug: Lidocaine
  • Drug: Adrenaline
• 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.
  Intervention: Drug: Dexmedetomidine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 15, 2013): 60
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2013
• Actual Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01964586
• Other Study ID Numbers: 2013/167
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Adnan Bayram, TC Erciyes University
• Study Sponsor: TC Erciyes University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Adnan Bayram, MD; TC Erciyes University

• PRS Account: TC Erciyes University
• Verification Date: October 2013