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

NCT06412861 | Completed

• 1 other identifier: ilke
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ketamine; Sedation; Gynecologic Disease

Keywords

ketamine; sedation; gynecological case

Outcome Measures

Primary Outcomes (2)

• Surgical satisfaction

  Surgical satisfaction survey: Was the level of sedation sufficient during local anesthesia administration? Was the level of sedation sufficient throughout the surgical procedure? Was your verbal communication level with the patient sufficient? Would you recommend this sedation method to other surgeons for this surgical procedure? Would you accept using the same sedation technique for your next surgical procedure with the patient? Scoring: Ratings are based on a scale of 0 to 2, where 0 indicates 'not at all', 1 indicates 'somewhat', and 2 indicates 'completely'. The scores are evaluated on a scale from the lowest '0' to the highest '10'."

  Postoperative procedure

• Incidence of lower extremity movement during the procedure

  The incidence of lower extremity movement indicative of inadequate sedation or analgesia during the procedure

  intraoperative

Secondary Outcomes (1)

• Adverse events (such as nausea, vomiting, airway obstruction, apnea, desaturation, respiratory depression, hypotension and bradycardia)

  30th minute postoperative

Study Arms (2)

ketamine-propofol

ACTIVE COMPARATOR

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.

Drug: Ketamine

fentanyl-propofol

ACTIVE COMPARATOR

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.

Drug: Fentanyl

Interventions

Ketamine 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.

Also known as: GROUP A

ketamine-propofol

Fentanyl 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.

Also known as: GROUP B

fentanyl-propofol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University Faculty of Medicine

Samsun, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 9356094 BACKGROUND

• 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.

  PMID: 10735789 BACKGROUND

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

Ketamine; Fentanyl

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• ilke tamdoğan

  ndokuz Mayıs University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomly assigned to one of two groups (1:1 ratio, parallel randomization) by randomization using the computer program "ResearchRandomizer" (Urbaniak and Plous 2013), conducted by a team member not involved in surgery or patient assessment. There will be 30 patients in each group.

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 14, 2024
• Study Start: April 20, 2024
• Primary Completion: June 30, 2024
• Study Completion: August 1, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-06

Locations

TU (1)