Propofol-ketamine or Propofol-fentanyl for Procedural Sedation in the Short-term Gynecological Case

NCT ID: NCT06412861

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-20
• Study Completion Date: 2024-08-01

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.

Detailed Description

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.

Conditions

Ketamine; Sedation; Gynecologic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

ketamine-propofol

0.5 mg/kg ketamine + 1 mg/kg propofol will be administered. Ramsey Sedation Score will be targeted to be \> 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered.

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

0.5 mg/kg ketamine + 1 mg/kg propofol, Ramsey Sedation Score \> 4 will be targeted. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered.

fentanyl-propofol

1 mcg/kg fentanyl + 1 mg/kg propofol will be administered. Ramsay Sedation Score will be targeted to be \> 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered.

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: DRUG

1 mcg/kg fentanyl + 1 mg/kg propofol will be administered. Ramsay Sedation Score will be targeted to be \> 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered.

Interventions

Ketamine

0.5 mg/kg ketamine + 1 mg/kg propofol, Ramsey Sedation Score \> 4 will be targeted. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered.

Intervention Type: DRUG

Fentanyl

1 mcg/kg fentanyl + 1 mg/kg propofol will be administered. Ramsay Sedation Score will be targeted to be \> 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered.

Intervention Type: DRUG

Other Intervention Names

GROUP A; GROUP B

Eligibility Criteria

Inclusion Criteria

• Patients between the ages of 18-65,
• American Society of Anesthesiologists (ASA) I-II,

Exclusion Criteria

• Patients with a known allergy to any of the drugs used in the study,
• Renal, hepatic, neuro-psychiatric, cardiovascular, or respiratory diseases, i
• intracranial space-occupying lesions,
• Pregnant women,
• Body mass index (BMI) > 30

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Ilke Tamdogan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ilke tamdoğan

Role: STUDY_DIRECTOR

ndokuz Mayıs University Faculty of Medicine

Locations

Ondokuz Mayıs University Faculty of Medicine

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Sa Rego MM, Watcha MF, White PF. The changing role of monitored anesthesia care in the ambulatory setting. Anesth Analg. 1997 Nov;85(5):1020-36. doi: 10.1097/00000539-199711000-00012. No abstract available.

Reference Type: BACKGROUND

PMID: 9356094 (View on PubMed)

Badrinath S, Avramov MN, Shadrick M, Witt TR, Ivankovich AD. The use of a ketamine-propofol combination during monitored anesthesia care. Anesth Analg. 2000 Apr;90(4):858-62. doi: 10.1097/00000539-200004000-00016.

Reference Type: BACKGROUND

PMID: 10735789 (View on PubMed)

Other Identifiers

ilke

Identifier Type: -

Identifier Source: org_study_id