NH600001, an etomidate analogue, provides gastrointestinal endoscopy sedation/anesthesia and reduces adrenocortical depression: two randomized controlled trials.

Summary

Across two double-blind multicenter RCTs (Phase II: n=160; Phase III: n=344), NH600001 0.25 mg/kg achieved noninferior endoscopy success compared with etomidate 0.30 mg/kg, while the 0.20 and 0.30 mg/kg doses did not meet noninferiority criteria. NH600001 reduced adrenocortical depression relative to etomidate as assessed by peri-procedural cortisol dynamics.

Key Findings

• NH600001 0.25 mg/kg was noninferior to etomidate 0.30 mg/kg for endoscopy success in Phase II (rate difference 5.0%, 95% CI −4.49 to 14.49).
• NH600001 0.20 and 0.30 mg/kg did not meet noninferiority criteria for procedural success versus etomidate.
• Peri-procedural cortisol assessments indicated reduced adrenocortical depression with NH600001 compared with etomidate.

Clinical Implications

NH600001 (0.25 mg/kg) may be preferred for GI endoscopy sedation in patients at risk for adrenal suppression or in settings where preserving adrenocortical function is desirable, while preserving procedural success.

Limitations

• Abstract provides limited detail on cortisol AUC results and longer-term adrenal outcomes.
• Generalizability may be limited by single-country (China) setting and endoscopy-specific context.

Future Directions

Clarify dose–response around 0.25 mg/kg; evaluate broader procedural contexts and higher-risk endocrine populations; and quantify adrenal recovery and clinical outcomes beyond 24–48 hours.