Propofol vs midazolam sedation for elective endoscopy in patients with cirrhosis: A systematic review and meta-analysis of randomized controlled trials

Table 1 Characteristics of included studies

Ref.	Study type	Inclusion criteria and outcomes	Medication	Intervention
Yoo et al[18], 2019, South Korea	RCT	Inclusion: Patients aged 19 to 75 yr for evaluation of portal hypertension; ASA I-III; Child-Turcotte-Pugh A, B, and C. Outcomes: Exacerbation of MHE, adverse events and discharge time; suggestive satisfaction measurements.	Propofol (20)	Propofol: 0.5 mg/kg in patients < 65 yr old or with body weight > 55 kg. In patients older than 65 yr and with body weight < 55 kg, the initial dose was 50% lower.
			Midazolam (20)	Midazolam: 0.03 mg/kg or 2 mg if the patient is < 65 yr old or with a body weight > 55 kg. In patients older than 65 yr and with body weight under 55 kg, the initial dose was 20% lower.
			Midazolam and propofol (20)	Midazolam: 0.03 mg/kg or 2 mg; Propofol: 20 mg. If the patient is > 65 yr old or has a body weight < 55 kg, the midazolam and propofol doses were respectively 20% and 50% lower.
Watanabe et al[19], 2018, Japan	RCT	Inclusion: Patients aged 20 to 80 yr, hepatic cirrhosis for the treatment of sclerosis, primary prophylaxis, Child- Turcotte-Pugh A and B. Outcomes: Exacerbation of MHE, patient and operator satisfaction, and adverse events.	Propofol (11)	Pentazocine 15 mg + Propofol 1% 20 mg IV followed by BIC of 3-5 mg/kg/h. In case of body movements or discomfort, 20 mg of Propofol (IV) was administered.
			Midazolam (12)	Pentazocine 15 mg + midazolam 2.5-5 mg. In case of body movement or signs of discomfort, an IV infusion with an additional 2.5 mg of midazolam was administered.
Ahmed et al[20], 2017, Egypt	RCT	Inclusion: Patients aged 40 to 60 yr, Child-Turcotte-Pugh B or C, patients willing to be part of the study. Outcomes: Procedure duration, recovery time, discharge time, sedation scores, and adverse events.	Propofol (50)	Propofol 1 mg/kg + 0.5 mcg/kg IV until a satisfactory level of sedation is reached. An additional dose of 0.2 mg/kg of propofol was administered in case of discomfort.
			Midazolam (50)	Midazolam 3 mg IV + fentanyl 0.5 mcg/kg until a satisfactory level of sedation is reached. A supplementary dose of 1 mg of midazolam was administered in case of an unsatisfactory level of sedation.
Agrawal et al[15], 2012, India	RCT	Inclusion: Patients aged 18 to 70 yr, hepatic cirrhosis confirmed and staged by Child-Turcotte-Pugh A and B, MELD, ASA I-III. Outcomes: Deterioration of psychometric tests before and after the examination, critical flicker frequency before and after, adverse events.	Propofol (40)	Propofol 0.5-1 mg IV, followed by an additional bolus if necessary.
			Midazolam (42)	Midazolam 0.5 - 1 mg IV, with an increasing dosage every 1-3 min, until a satisfactory level of sedation is reached.
			No-sedation (45)
Correia et al[21], 2011, Brazil	RCT	Inclusion: Patients aged 18 to 75 yr, with hepatic cirrhosis, Child-Turcotte-Pugh A, B or C, ASA I-III. Outcomes: Procedure duration, discharge time, recovery time, and adverse events.	Propofol (100)	Midazolam 0.05 mg/kg with a dosage of 1 mg every 2 min, if necessary, up to a maximum dose of 0.1 mg/ kg or 10 mg + 50 mcg of fentanyl.
			Midazolam (110)	Propofol 0.25 mg/kg with a dosage of 20-30 mg, if necessary, every 30-60 s up to a maximum dose of 400 mg + fentanyl 50 mcg.
Khamaysi et al[16], 2011, Israel	RCT	Inclusion: Compensated liver cirrhosis, Child-Turcotte-Pugh A and B. Outcomes: Sub-clinical hepatic encephalopathy before and after, procedure duration, induction time, recovery time, discharge time, adverse events.	Propofol (31)	Propofol: 30-50 mg followed by repeated dosages of 10-20 mg at intervals of 15 s, at the endoscopist's discretion, up to a 70-100 mg dose, considering the level of satisfactory sedation.
			Midazolam (30)	Midazolam: (0.5-1.0 mg) administered by intravenous bolus injection, with incremental dosages at intervals of approximately 1 to 3 min until a satisfactory level of sedation for the procedure was reached (variation of 3-6 mg).
			Control/No-sedation (30)
Riphaus et al[17], 2009, Germany	RCT	Inclusion: Patients over 18 yr old diagnosed with hepatic cirrhosis, Child-Turcotte-Pugh A, B and C, without using benzodiazepine or antiepileptics, ASA I-III. Control group: Non-cirrhotic. Outcomes: Acute deterioration of minimal encephalopathy before and after sedation, procedure duration, recovery time, and adverse events.	Propofol (40)	Propofol: 40 mg of propofol 1% or 60 mg in patients weighing 70 kg; an extra dose of 10 mg was administered if necessary.
			Midazolam (20)	Midazolam: 2.5 mg IV, with repeated doses administered to ensure satisfactory sedation within a limit of 7.5 mg total.
			Control/No-sedation (20)
Weston et al[22], 2003, United States	RCT	Inclusion: Patients over 18 yr old, confirmed hepatic cirrhosis, Child-Turcotte-Pugh A and B, ASA I-II. Outcomes: Procedure duration, recovery time, discharge time, and adverse events.	Propofol (10)	Propofol: 30-50 mg IV, followed by a 10-20 mg dosage every 15 s, at the discretion of an endoscopist or nurse, until a satisfactory level of sedation is reached.
			Midazolam (10)	Midazolam: 0.5-1 mg + meperidine (12.5-25 mg), with an additional dosage every 1-3 min if necessary.

MHE: Minimal hepatic encephalopathy; MELD: Model for End-Stage Liver Disease.