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. 2021 May 18;2021(5):CD007579. doi: 10.1002/14651858.CD007579.pub3

Abdollahpour 2015.

Study characteristics
Methods RCT
Participants Inclusion criteria:
  • ASA I or II, age 18‐40, no contraindications to spinal, no allergy to local anaesthesia or study medications, absence of neuropathy, consent for spinal.

  • 75 women randomised, no exclusions but we only used data from 2 groups as we exclude opioid drugs. So 50 women are in our analysis


Exclusion criteria:
  • GIT disease, delivery before 36 weeks, received anti‐emetics in the 24 hours prior to surgery, pregnancy‐induced hypertension or problems during LUSCS, administration of narcotic agents during LUSCS.

Interventions Intervention: sedative (Comparison 6)
  • Midazolam (IT)

  • 0.02 mg/kg diluted to 1 mL with normal saline.

  • N = 25.


Intervention: opioid (excluded from our synthesis)
  • Sufentanil (1.5 mcg in 0.3 mL + 0.7 mL normal saline (IT).

  • N = 25


Comparator: placebo
  • Normal saline (1 mL IT).

  • N = 25.

Outcomes Pre‐specified outcomes:
Analgesia quality:
‐ Onset (sensory, motor)
‐ Recovery (sensory, motor)
‐ Time to request additional analgesia
Complications:
‐ Nausea
‐ Vomiting
‐ Shivering
‐ Hypotension
Notes Setting: Semnan University of Medical Sciences, Semnan, Iran.
Dates: 2012 to 2013,
Funding source: the study supported by Semnan University of Medical Sciences, Semnan, Iran.
Declaration of interest: not reported.
Spinal anaesthesia with bupivacaine
We include only the data comparing midazolam vs placebo as sufentanil is an opioid
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote:"random block method"
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Not described
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not described
Incomplete outcome data (attrition bias)
All outcomes Unclear risk None described
Selective reporting (reporting bias) Unclear risk We were unable to assess the trial protocol
Other bias Unclear risk Baseline characteristics (except age) not described