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Table 1 Schedule of patient enrollment, study interventions, and outcome measurements

From: Effects of opioid-free total intravenous anesthesia on postoperative nausea and vomiting after treatments of lower extremity wounds: protocol for a randomized double-blind crossover trial

 

Study period

Timepoint

Enrollment

Allocation

Post-allocation

Closeout

Preoperative visit

Before surgery

During surgery

PACU

24 h after surgery

48 h after surgery

Hospital discharge

Enrollment

       

 Inclusion criteria

 × 

      

 Exclusion criteria

 × 

      

 Written informed consent

 × 

      

 Baseline characteristics

 × 

      

 PONV risk score

 × 

      

 Randomization

 

 × 

     

 Allocation

 

 × 

     

Interventions

       

 Sequence 1: OFA-OBA

  

 × 

    

 Sequence 2: OBA-OFA

  

 × 

    

Endpoint measures

       

 Incidence of PONV

   

 × 

 × 

 × 

 

 Severity of PONV

   

 × 

 × 

 × 

 

 Antiemetic rescue therapy

   

 × 

 × 

 × 

 

 Postoperative pain scores

   

 × 

 × 

 × 

 

 The worst pain

   

 × 

 × 

 × 

 

 Need for rescue analgesia

   

 × 

 × 

 × 

 

 Level of sedation

  

 × 

 × 

   

 Hypotension

  

 × 

 × 

   

 Bradycardia

  

 × 

 × 

   

 Hypertension

  

 × 

 × 

   

 Tachycardia

  

 × 

 × 

   

 Hypoxemia

   

 × 

 × 

 × 

 

 Psychotomimetic/dissociative effects

   

 × 

 × 

 × 

 

 Time to extubation

   

 × 

   

 Length of PACU stay

   

 × 

   

Perioperative data

       

 Patient satisfaction

      

 × 

 In hospital major complications

      

 × 

 Length of anesthesia

   

 × 

   

 Length of procedure

   

 × 

   

 Postoperative length of hospital stay

      

 × 

  1. According to SPIRIT statement of defining standard protocol items for clinical trials
  2. OFA opioid-free anesthesia, OBA opioid-based anesthesia, PONV postoperative nausea and vomiting, PACU postanesthesia care unit