Handa Tsutsui 2007.
| Methods |
Study design: Randomized controlled trial Study grouping: Parallel group |
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| Participants |
Baseline Characteristics Nitrous oxide‐free – A Number randomized: 23 Number analysed: 23 Age (mean): 35 (± 3.3) % male: 0 Type of surgery: Transvaginal US guided oocyte retrieval for in‐vitro fertilization Nitrous oxide‐based – A Number randomized: 24 Number analysed: 24 Age (mean): 36 (± 7.8) % male: 0 Type of surgery: Transvaginal US guided oocyte retrieval for in‐vitro fertilization Included criteria: Women ASA class I ‐ II, unpremedicated and undergoing scheduled transvaginal ultrasound‐guided oocyte retrieval were recruited Excluded criteria: NR |
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| Interventions |
Intervention Characteristics Nitrous oxide‐free – A Name: Propofol + air Induction: Propofol was started at target concentration using a Diprifusor™ anaesthesia pump Maintenance: Oxygen‐enriched air (FiO₂ 0.5). Participants experiencing movement immediately had their propofol plasma‐site concentration increased to 6 ‐ 10 mcg/ml. Target concentration of propofol was started at 4 mcg/ml for the first participant. Subsequent participants received target concentration 0.5 mcg/ml higher or lower using up/down sequential allocation. If the response of the previous woman was movement, the target concentration for the next participant was increased by 0.5 mcg/ml. If the response was no movement, the next target concentration was reduced Recovery: Recovery time (mins) 11 (± 6.2) Other drugs used: NR Premedication: To reduce vascular pain, 2% lidocaine 1 mg/kg was administered IV before propofol induction Duration of anaesthesia (mins): NR Nitrous oxide‐based – A Name: Propofol + nitrous oxide Induction: Propofol was started at target concentration using a Diprifusor™ anaesthesia pump Maintenance: After induction of anaesthesia, mask ventilation was maintained with 50% N₂O and 50% oxygen. Participants experiencing movement immediately had their propofol plasma‐site concentration increased to 6 ‐ 10 mcg/ml.Target concentration of propofol was started at 4 mcg/ml for the first participant. Subsequent participants received target concentration 0.5 mcg/ml higher or lower using up/down sequential allocation. If the response of the previous woman was movement, the target concentration for the next participant was increased by 0.5 mcg/ml. If the response was no movement, the next target concentration was reduced Recovery: NR. Recovery time (mins)12 (± 4.7) Other drugs used: NR Premedication: To reduce vascular pain, 2% lidocaine 1 mg/kg was administered iv before propofol induction Duration of anaesthesia (min): NR Monitoring: as described above, up/down dosing method used. Depth of anaesthesia in both groups should be equivalent |
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| Outcomes | Accidental awareness "All women were interviewed about memory recall and post‐procedure pain in the recovery room." "Direct questioning in the recovery room yielded no complaint of recall of the procedure or anaesthesia" |
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| Identification |
Country: Japan Setting: NR Authors name: F. Handa‐Tsutsui Institution: Department of Anesthesiology, Saitama Medical Center, Kamoda Email: PXN01110@nifty.com Address: Dept. of Cardiac Surgery, Saitama Medical School, Moroyama, Saitama, 350‐0495 Japan |
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| Aim of study | Determine the target concentration of propofol required to prevent movement in 50% (Cp50) and 95% (Cp95) of women during oocyte retrieval, and investigated whether supplemental N₂O modified the Cp50 and Cp95 | |
| Notes | Sponsorship source: Saitama MedicalCenter. Neither author has corporate support or any relationship with commercial companies | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomly assigned into two groups using random table:" Comment: No further details |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Patients were randomly assigned into two groups using random table:" Comment: No further details |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: Presume anaesthetists not blinded. No mention of participant blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: Not clear if same investigators asked about recall. No mention of participant blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: No attrition |
| Selective reporting (reporting bias) | Low risk | Comment: All relevant outcomes described in Methods reported |
| Other bias | Low risk | Comment: None identified |