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Table 1 Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT)

From: Preoperative oral diazepam for intraoperative blood pressure stabilisation in hypertensive patients undergoing vitrectomy under retrobulbar nerve block anaesthesia: study protocol for a randomised controlled trial

Timepoint

Study period

Enrolment

Allocation

Perioperation

Post-surgery

Follow-up

Recruitment

(1 day before operation)

Randomisation

(1h before operation)

Before and after anaesthesia, every 5 min from the start of operation

1 h after operation

Within one month after operation

Enrolment:

 Eligibility screen

×

    

 Informed consent

×

    

 Randomisation and allocation

 

×

   

Interventions:

 Diazepam group (oral diazepam 2.5 mg before operation)

 

×

   

 Placebo group (oral placebo before operation)

 

×

   

Assessments:

 Blood pressure

×

×

×

×

×

 Heart rate

×

×

×

×

×

 Adverse reactions

 

×

×

×

×