Effects of Dexmetomidine and Remifentanil Used for Controlled Hypotension in Septorhinoplasty Surgery on Cardiac Electrophysiology: Prospective Randomized Study
Effects of Dex
1 other identifier
interventional
72
0 countries
N/A
Brief Summary
Our aim in this treatment was to reveal the effects of remifentanil and dexmetomidine, which we used to provide controlled hypotension in septorhinoplasty surgery, on cardiac electrophysiology. We planned to compare the patients by recording preoperative and postoperative ECGs. We also planned to record the patients' intraoperative blood pressure, saturation, and pulse rate, rickeragitation scale, and vas score.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2023
Shorter than P25 for not_applicable
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
November 14, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedNovember 18, 2023
November 1, 2023
2 months
November 14, 2023
November 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
iceb
Qt\\Qrs
preoperative and postoperative (immediatly after extubation)
Secondary Outcomes (4)
Riker Agitation Scale
Immediately after extubation
mean arterial pressure
when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubasion
heart rate
when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubasion
Numeric Rating Scale
Postoperative 0-2 hours
Study Arms (2)
Effects of Dexmetomidine
ACTIVE COMPARATORPatients in this group will be given dexmedetomidine infusion during the intraoperative period to provide controlled hypotension.
Effects of Remifentanil
ACTIVE COMPARATORPatients in this group will be given remifentanil infusion during the intraoperative period to provide controlled hypotension.
Interventions
After the induction of general anesthesia, one group (Group: 1) will be administered dexmedotomidin infizyon and group (Group :2)remifentanil
Eligibility Criteria
You may qualify if:
- patients with an ASA score of I and between the ages of 17-45 years, who were to undergo general anesthesia with sevofulurane were included in the study.
You may not qualify if:
- Patients aged \<17 and \>45 years, patients with liver and/or kidney failure, obese patients (BMI \>30), trauma patients, ASA II-III-IV patients, patients with bleeding disorders, those using drugs that may affect the coagulation system, patients with cardiomyopathy, cerebrovascular disease, immobility, and malnutrition were excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- HTosunSoner
Study Record Dates
First Submitted
November 14, 2023
First Posted
November 18, 2023
Study Start
December 1, 2023
Primary Completion
February 1, 2024
Study Completion
March 30, 2024
Last Updated
November 18, 2023
Record last verified: 2023-11