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. 2018 Jun 4;2018(6):CD009642. doi: 10.1002/14651858.CD009642.pub3

Omar 2013.

Methods Randomized, placebo‐controlled trial. Participants, personnel, and outcome assessors were blinded.
 This study hypothesized that lidocaine may be effective in producing controlled hypotension in patients undergoing functional endoscopic sinus surgery.
The study was conducted in Saudi Arabia from October 2011 to December 2012.
Participants Number assessed for eligibility: N/A
Number randomized: 48 → 24:24
Number analysed: 24:24
Inclusion criteria
ASA I to II adults (age 18 to 50) planned to undergo functional endoscopic sinus surgery.
Exclusion criteria
Patients with hepatic, renal, cardiovascular, neuromuscular, or hematological disorders were excluded. Patients on anticoagulant, opioid, or sedative drugs were also excluded.
Baseline details
Experimental group (n = 24)
Mean age (years): 36.7
M = 54.1%, F = 46.9%
Mean BMI (kg/m2): 27.9
ASA I/II: 15:9
Duration of anaesthesia (mins): 87
Main surgical procedure: functional endoscopic sinus surgery
Control group (n = 24)
Mean age (years): 36.3
M = 58.3%, F = 41.7%
Mean BMI (kg/m2): 26.7
ASA I/II: 17:7
Duration of anaesthesia (min): 99
Main surgical procedure: functional endoscopic sinus surgery
Interventions Experimental group (24 patients)
Patients received a bolus with 1.5 mg/kg lidocaine (1% solution) after endotracheal intubation, continuous infusion with a rate of 1.5 mg/kg/hr (0.15 ml/kg/hr). On conclusion of surgery, the study medications and sevoflurane were discontinued.
Control group (24 patients)
Control patients received an equal volume of saline.
Outcomes The primary endpoint of the study was surgery field quality.
Dichotomous

  1. Postoperative nausea and vomiting during PACU

  2. Side effects (intraoperative bradycardia)

  3. Need for ketorolac postoperatively (VAS pain score 1 to 4)

  4. Need for fentanyl postoperatively (VAS pain score > 4)


Continuous

  1. Intraoperative quality of surgical field (surgical field score 0 to 5), every 15 min during surgery (data presented as median with IQR)

  2. Intraoperative mean heart rate every 15 min during surgery (data presented graphically)

  3. Intraoperative MAP every 15 min during surgery (data presented graphically)

  4. Intraoperative fentanyl dose (µg)

  5. Intraoperative mean end‐tidal sevoflurane concentrations every 15 min during surgery (data presented graphically)

  6. Length of PACU stay

  7. Pain score (VAS 0 to 10) at rest during PACU at 15 min, 30 min, and 60 min (data presented as median with IQR, asymmetric distribution at 60 min)
Notes

  1. Small trial sample size (< 200 patients)

  2. Power analysis performed (surgical field quality, n = 21)


Medication
"If pain VAS score was 1–4, 30 mg of IV ketorolac was given. If pain score > 4 or if the pain was not relieved by ketorolac, fentanyl 0.5 µg/kg was given. Ondansetron 4mg IV was given as a rescue antiemetic in case of PONV. Phenylephrine was used in PACU with the same doses used intraoperatively to treat hypotension."
Anaesthesia
 The anaesthesia regime was standardized in both groups.
Funding
 No funding mentioned
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "immediately after endotracheal intubation, patients were randomly assigned to 2 equal groups using computerized randomization tables…"
Allocation concealment (selection bias) Unclear risk Quote: "…in closed envelopes…" Not mentioned sequentially numbered, opaque envelopes.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "the hospital pharmacists who were not involved in the study prepared the study medications in 4 different coded syringes…", "...the attendant anaesthesiologist who was blinded to group allocation." Patients could not know group allocation due to adequate blinding of personnel.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "pain was assessed in PACU by a nurse who was blinded to group allocation…"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No withdrawals, no exclusions.
Selective reporting (reporting bias) Unclear risk There is no reference to a trial registry and no published study protocol.
Other bias Low risk The study appears to be free of other sources of bias.