Sedation Clinical Trial
Official title:
Comparison of Propofol-ketamine and Propofol-fentanyl Sedation in Short-term Gynecological Cases
Comparison of fentanyl-propofol and ketamine-propofol combination for sedation in brief gynecological cases Our study aimed to evaluate ketamine-propofol and fentanyl-propofol combinations in short-term gynecological cases in terms of hemodynamic parameters, recovery, complications, patient and physician comfort.
Procedural sedation is widely used in various medical procedures worldwide, aiming to suppress consciousness adequately and provide sufficient analgesia while preserving the patient's cardiorespiratory function during painful or unpleasant interventions (1,2). Many drugs are used alone or in combination for this purpose (e.g., benzodiazepines, opioids such as fentanyl and remifentanil, midazolam, ketamine, propofol, dexmedetomidine) (6). This prospective, randomized, double-blind study will evaluate the effectiveness of ketamine-propofol and fentanyl-propofol combinations during short-term gynecological procedures by comparing the frequency of lower extremity movements in sedated patients. Participants eligible for the study will include individuals aged 18-65 with American Society of Anesthesiologists (ASA) physical status I or II undergoing short gynecological procedures lasting less than 30 minutes. Participants with allergies to study medications, obesity, or behavioral disorders will be excluded. All participants will provide written informed consent the day before the procedure. Enrolled participants will be divided into two groups: Group K, receiving ketamine and propofol, and Group F, receiving fentanyl and propofol. Heart rate (HR), arterial blood pressure (ABP), peripheral oxygen saturation (SpO2), Ramsey Sedation Score( 1: Awake; agitated or restless or both, 2: Awake; cooperative, oriented, and tranquil,3: Awake but responds to commands only, 4: Asleep; brisk response to light glabellar tap or loud auditory stimulus,5: Asleep; sluggish response to light glabellar tap or loud auditory stimulus, 6: Asleep; no response to glabellar tap or loud auditory stimulus)( RSS), and Facial Pain Score(0:No hurt- 10:Hurts worst (FPS) will be evaluated at five time points: T1 (pre-induction), T2 (1 minute post-induction), T3 (3 minutes post-induction), T4 (end of surgery), and T5 (30 minutes postoperatively). ) In Group K, ketamine-propofol will be prepared in a 1:1 ratio (both 10 mg/mL) in the same syringe, while in Group F, fentanyl (1-2 mcg/kg) and propofol (1 mg/kg) will be prepared separately. Sedation will be initiated with 0.2 mL/kg of ketofol. Surgery will commence if RSS > 4; if the desired sedation level is not achieved, a rescue dose of 0.5 mg/kg propofol bolus will be administered. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03399019 -
Bispectral Index(BIS) on Depth of Sedation With Dexmedetomidine, Propofol and Midazolam During Spinal Anesthesia
|
N/A | |
| Completed |
NCT03220880 -
Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures
|
||
| Recruiting |
NCT04820205 -
Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children
|
N/A | |
| Recruiting |
NCT04549623 -
End-Tidal Carbon Dioxide Monitoring Device for Sedation During Endoscopic Ultrasonography
|
N/A | |
| Recruiting |
NCT04822064 -
Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation
|
N/A | |
| Completed |
NCT01527903 -
A Comparison Between Propofol-Remifentanil and Midazolam-Remifentanil Sedation in the Intensive Care Unit
|
Phase 4 | |
| Completed |
NCT01001533 -
Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation
|
N/A | |
| Completed |
NCT00747721 -
Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU
|
Phase 1 | |
| Completed |
NCT00158873 -
Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects
|
Phase 4 | |
| Terminated |
NCT00205517 -
Sedation and Psychopharmacology in Critical Care
|
N/A | |
| Recruiting |
NCT04096768 -
The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation
|
Phase 3 | |
| Active, not recruiting |
NCT05082623 -
The Effect of Music on Delirium, Pain, Need of Sedation, Anxiety and Vital Parameters
|
N/A | |
| Suspended |
NCT03285165 -
Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT04788589 -
Sedation and Ventilator Weaning Protocol in PICU
|
N/A | |
| Completed |
NCT03425474 -
Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy
|
Phase 3 | |
| Recruiting |
NCT06061159 -
The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction
|
Phase 4 | |
| Completed |
NCT02171910 -
Doxapram as an Additive to Propofol Sedation in Sedation for ERCP
|
Phase 4 | |
| Completed |
NCT02211118 -
Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD
|
Phase 4 | |
| Completed |
NCT01694745 -
EUROpean Pain Audit In Neonates
|
N/A | |
| Completed |
NCT00997126 -
Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation
|
Phase 4 |