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. 2019 Mar 29;2019(3):CD012212. doi: 10.1002/14651858.CD012212.pub2

Ooi 1992.

Methods Design: single‐blind, prospective randomized controlled trial
 Country: UK
 Multisite: no
 International: no
 Treatment duration: perioperative period
 Follow‐up: not specified
 Operative procedure(s): therapeutic abortion
 Randomization unit: participants
 Analysis unit: individual
Participants
  1. 30 participants enrolled

  2. ASA I to II female participants aged 18 to 39 undergoing ambulatory therapeutic abortion of pregnancy before 14 weeks gestation


No exclusion criteria were provided.
Randomized to:
  1. group I (n = 15, 50%);

  2. group II (n = 15 50%);

  3. 1 patient from group II was excluded because they were unable to complete required psychomotor testing.


Main characteristics of participants:
  1. age (mean, range): group II 24.5 years, 18 to 33; group II 27.2 years, 18 to 39;

  2. number of females/males: 30/1.

Interventions
  1. Supplemental fluid group (intervention): preoperative bolus of 20 mL/kg 4% glucose/0.18% saline solution

  2. Conservative fluid group (control): no preoperative bolus


Co‐interventions: none stated
Outcomes
  1. Nausea was assessed using a questionnaire.

  2. Nausea severity was recorded on a 4‐point scale: 1 = none; 2 = slight; 3 = moderate; 4 = severe. This was completed during PACU stay and reported as a dichotomous outcome.

  3. Also assessed on the postoperative questionnaire, using the same scale, were anxiety, pain, drowsiness, headache, dizziness, thirst, sore throat, weakness, and muscle ache.

  4. Psychomotor testing used a 4‐choice, computer‐controlled visual reaction time test and a letter cancellation test was completed preoperatively and postoperatively. Scores were reported for both periods.

  5. Also measured were time to eye opening, time until able to obey commands, and time until able to state date of birth, and biochemical measurements including serum glucose, plasma osmolality, and urine osmolality.

Notes Trial registration: not stated
 Funder: not stated
 A priori sample size estimation: stated on page 576
 Conducted: dates not stated
 Declared conflicts of interest: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants were randomly allocated, but no information on the randomization process was provided.
Allocation concealment (selection bias) Unclear risk Participants were randomly allocated, but no information on the randomization process was provided.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk It is not stated that participants or personnel were blind to group allocation.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk All postoperative testing was completed by a blinded observer.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk One participant was excluded. This was explained in the text.
Selective reporting (reporting bias) Low risk All outcomes were reported.
Other bias Low risk There were no other sources of bias.