Women undergoing ultrasound controlled transvaginal oocyte retrieval for in vitro fertilisation Pregnancy and Childbirth
Conditions
Interventions
1. Intravenous parecoxib 40 mg followed by IV midazolam 5 mg bolus 15 minutes before the procedure
2. Intravenous fentanyl 50 mcg followed by IV midazolam 5mg bolus 15 min prior to the
Sponsors
University Malaya Medical Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women undergoing ovum pick up aged 18 to 45 years old 2. Suitable for conscious sedation
Exclusion criteria
Exclusion criteria: 1. Previous history of hypersensitivity or contraindication to midazolam/fentanyl/parecoxib 2. Women not suitable for conscious sedation OPU e.g., medical comorbidity such as hypertension on treatment, inflammatory bowel disease, ischemic heart disease and heart failure on anticoagulants, history of bronchospasm, history of cerebrovascular disease and upper GI perforation, severe hepatic impairment 3. Extreme anxiety 4. Anticipated complicated ovum pick up: extensive endometriosis, pelvic adhesions, difficult to access ovaries 5. Prior issues with conscious sedation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful sedation assessed using the Procedural Sedation Assessment Survey (PROSAS) at 30 minutes after awakening in the recovery area. “In accordance with patients’ priorities, procedural sedation was judged as successful when there was no adverse event, no issues with sedation leading to an incomplete procedure, when patient-reported procedural discomfort was scored 2 or less, and the patient was comfortable with the level of sedation obtained with a sedation preference score of between -2 and 2” | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain measured using the numerical rating scale 0-10 at awakening, 15, 30, 45, 60 minutes and just before discharge 2. Nausea measured by asking Yes or No at awakening, 15, 30, 45, 60 minutes and just before discharge 3. Vomiting measured by asking Yes or No at awakening, 15, 30, 45, 60 minutes and just before discharge 4. Surgeon satisfaction with the sedation-pain relief during ovum pick up measured using the numerical rating scale after completing the oocyte retrieval procedure 5. Hypotension/hypertension (systolic blood pressure [SBP] 160 mmHg) measured using automated blood pressure during procedures and upon awakening, 15, 30, 45, 60 minutes and just before discharge 6. Tachycardia/bradycardia (heart rate > 120/min or < 50/min) measured using automated pulse oximetry during procedures and upon awakening, 15, 30, 45, 60 minutes and just before discharge 7. Oxygen desaturation (any episode of desaturation <90% on pulse oximetry) measured using automated pulse oximetry during procedures and upon awakening, 15, 30, 45, 60 minutes and just before discharge 8. Number of oocytes retrieved and charted using the standardised form provided in the Fertility Unit during the procedure, and the result will be obtained on completion of embryologist report | — |
Countries
Malaysia
Outcome results
None listed