Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412861
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2024-05-07
Brief Title:
Propofol-ketamine or Propofol-fentanyl for Procedural Sedation in the Short-term Gynecological Case
Sponsor:
Ondokuz Mayıs University
Organization:
Ondokuz Mayıs University
Study Overview
Official Title:
Comparison of Propofol-ketamine and Propofol-fentanyl Sedation in Short-term Gynecological Cases
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
Procedural sedation is widely used in various medical procedures worldwide aiming to suppress consciousness adequately and provide sufficient analgesia while preserving the patients cardiorespiratory function during painful or unpleasant interventions 12 Many drugs are used alone or in combination for this purpose eg 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 tranquil3 Awake but responds to commands only 4 Asleep brisk response to light glabellar tap or loud auditory stimulus5 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 Score0No hurt- 10Hurts 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 11 ratio both 10 mgmL in the same syringe while in Group F fentanyl 1-2 mcgkg and propofol 1 mgkg will be prepared separately Sedation will be initiated with 02 mLkg of ketofol Surgery will commence if RSS 4 if the desired sedation level is not achieved a rescue dose of 05 mgkg propofol bolus will be administered
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 tranquil3 Awake but responds to commands only 4 Asleep brisk response to light glabellar tap or loud auditory stimulus5 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 Score0No hurt- 10Hurts 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 11 ratio both 10 mgmL in the same syringe while in Group F fentanyl 1-2 mcgkg and propofol 1 mgkg will be prepared separately Sedation will be initiated with 02 mLkg of ketofol Surgery will commence if RSS 4 if the desired sedation level is not achieved a rescue dose of 05 mgkg propofol bolus will be administered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None