A study protocol for patient inout-patient surgery on local anaesthetic and self controlled sedation (PCS) with propofol in three different concentrations per dose (PROP-3). The study is a comparison of three different dose levels of propofol .

Clinical Study Protocol An open phase IV,RCT, evaluating patient controlled sedation, in three different dosages of propofol in healthy subjects undergoing elective gynaecological out-patient surgery in local anaesthesia. - PROP-3

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001373-33-SE

Enrollment

Unknown

Registered

2016-08-15

Start date

2017-02-17

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecological outpatient surgery

Interventions

Trade Name: Propofol-Lipuro 5mg/mL Product Name: Propofol Pharmaceutical Form: Emulsion for injection/infusion INN or Proposed INN: Propofol Other descriptive name: PROPOFOL Concentration unit: mg/ml

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Obtained Inform Consent Healthy women ASA classification I-II Age 50-70 years, kakuasier BMI 20-30 Elective outpatient gynecological procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Psyciatric disorder Use of Antipsycotics, Sedatives, Opioids Smoking Allergy to propofol Abuse of drugs and alcohol Incapable of giving consent Chronic pelvic pain Positive pregnancy test , measured in woman with childbearing potential Smoking Allergy to propofol Abuse of drugs and alcohol Incapable of giving consent

Design outcomes

Primary

Measure	Time frame
Main Objective: Identifying the most optimal dose of propofol without opioids to reduce risk for depressed respiration( oxigen - saturation) while maintaining adequate moderate sedation ( EEG and response to verbal command ) and comfort with patient-controlled sedation( need of alfentanil/ propofol). ;Secondary Objective: Concentration of propofol in plasma Patient satisfaction and recovery ;Primary end point(s): To evaluate the risk of depressed respiration in different dosage of propofol administrated as patient controlled sedation. Depressed respiration defined as oxygen saturation below 94% To evaluate level of pain Using NRS defined as 3 or more before surgery and every five minutes or if patient verbalises pain during surgery To evaluate EEG pattern during patient controlled sedation To evaluate need of rescue medication, alfentanil and/ or propofol ;Timepoint(s) of evaluation of this end point: Continuous measurement of respiratory rate for 15-90 minutes depending on the operating length Continuous measuring of puls saturation NRS registration every five minutes	—

Measure

Time frame

Main Objective: Identifying the most optimal dose of propofol without opioids to reduce risk for depressed respiration( oxigen - saturation) while maintaining adequate moderate sedation ( EEG and response to verbal command ) and comfort with patient-controlled sedation( need of alfentanil/ propofol). ;Secondary Objective: Concentration of propofol in plasma Patient satisfaction and recovery ;Primary end point(s): To evaluate the risk of depressed respiration in different dosage of propofol administrated as patient controlled sedation. Depressed respiration defined as oxygen saturation below 94% To evaluate level of pain Using NRS defined as 3 or more before surgery and every five minutes or if patient verbalises pain during surgery To evaluate EEG pattern during patient controlled sedation To evaluate need of rescue medication, alfentanil and/ or propofol ;Timepoint(s) of evaluation of this end point: Continuous measurement of respiratory rate for 15-90 minutes depending on the operating length Continuous measuring of puls saturation NRS registration every five minutes

—

Secondary

Measure	Time frame
Secondary end point(s): To evaluate the plasma concentration of propofol at certain time points To evaluate patient satisfaction with self controlled sedation To evaluate the surgeons opinion of procedure feasibillity;Timepoint(s) of evaluation of this end point: Continuously during the surgery with EEG. Patient satisfaction control one hour after the end of surgery, and telephone follow-up after 48 hours Surgeons satisfaction direct after surgery	—

Measure

Time frame

Secondary end point(s): To evaluate the plasma concentration of propofol at certain time points To evaluate patient satisfaction with self controlled sedation To evaluate the surgeons opinion of procedure feasibillity;Timepoint(s) of evaluation of this end point: Continuously during the surgery with EEG. Patient satisfaction control one hour after the end of surgery, and telephone follow-up after 48 hours Surgeons satisfaction direct after surgery

—

Countries

Sweden

Contacts

Public ContactANOPIVA

Region Ostergotland

christina.eintrei@liu.se+460101031835

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026