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document
Propofol sedation with bispectral index monitoring is useful for endoscopic submucosal dissection : a randomized prospective phase II clinical trial . BACKGROUND AND STUDY AIMS Endoscopic submucosal dissection ( ESD ) has become a standard treatment . However , the treatment time tends to be relatively long and insufflation and manipulation of the endoscope can increase pain and discomfort . We aimed to find an optimal method for sedation during ESD . PATIENTS AND METHODS Patients scheduled to undergo ESD for early gastric cancer or adenoma were randomly assigned to sedation with midazolam or propofol , and consciousness level was evaluated by bispectral index ( BIS ) monitoring . Primary end points of effectiveness ( three parameters ) and secondary end points of safety during ESD and after return to the ward were compared between the groups . Study registration was in the UMIN Clinical Trial Registry ( UMIN 000001497 ) , and the institutional trial number was KDOG 0801 . RESULTS From June 2008 through June 2009 , we enrolled 178 patients ( 90 midazolam , 88 propofol ) . Regarding safety after ESD , recovery was significantly better in the propofol group immediately after and at 1 hour and 2 hours after return to the ward ( P < 0.001 ) . The number of patients who required a continuous supply of oxygen 2 hours after returning to the ward was significantly lower in the propofol group ( midazolam 18 ; propofol 6 ; P = 0.010 ) . Though propofol seemed to be better for effectiveness and safety , there were no statistically significant differences for all three primary end points and the safety parameters ( hypotension , hypoxia , bradycardia ) . CONCLUSIONS Propofol with BIS monitoring improved recovery of patients after ESD , though this study was underpowered to prove the effectiveness and safety of propofol .
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Intervention_Pharmacological
Propofol
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Intervention_Pharmacological
midazolam
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Intervention_Pharmacological
propofol
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Intervention_Pharmacological
Propofol
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Outcome_Other
safety
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Outcome_Other
recovery
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Outcome_Other
number of patients who required a continuous supply of oxygen
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Outcome_Other
effectiveness
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Outcome_Other
safety
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Outcome_Physical
safety parameters
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Outcome_Physical
hypotension
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Outcome_Physical
hypoxia
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Outcome_Physical
bradycardia
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Outcome_Other
recovery
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Participant_Condition
early gastric cancer or adenoma
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Participant_Sample-size
178