Feasibility and safety of an analgesia-first strategy without hypnotic sedatives in adult patients admitted to the intensive care unit after neurosurgical craniotomy: a protocol for a single-arm, single-center exploratory prospective study

By
Yu-Mei Wang
Ying Tian
Shu-Ya Wang
Guang-Qiang Chen
Guang-Zhi Shi
June 10, 2026
0 min

Frontiers In Medicine

Overview

This study investigates the feasibility and safety of an analgesia-first strategy without hypnotic sedatives in adult neurosurgical patients in the ICU. The primary endpoint focuses on successful protocol management within the first 24 hours post-initiation.

Background

Effective pain management and sedation are critical in the ICU, particularly for neurosurgical patients who may experience agitation that complicates their recovery. Minimizing hypnotic sedation can enhance patient assessment and reduce adverse outcomes, yet specific safety considerations for neurocritical care patients must be addressed. This study aims to fill the gap in understanding the implications of an analgesia-first approach in this vulnerable population.

Data Highlights

Endpoint	Description
Primary Endpoint	Successful protocol management during the first 24 hours
Key Safety Endpoints	Agitation, accidental extubation, respiratory depression, etc.
Secondary Endpoints	Analgesic exposure, ICU length of stay, in-hospital mortality

Key Findings

The study will enroll 65 adult patients post-neurosurgical craniotomy.
Patients will receive remifentanil-based analgesia with specific titration guidelines.
Rescue sedation with midazolam or propofol is permitted for safety.
Primary endpoint is defined as absence of protocol failure within 24 hours.
Significant agitation and neurological deterioration are key safety concerns.

Clinical Implications

Implementing an analgesia-first approach may enhance patient comfort and safety while allowing for necessary neurological assessments. Careful monitoring for agitation and other safety endpoints is essential to prevent complications in this population.

Conclusion

The study aims to provide insights into the safety and feasibility of minimizing hypnotic sedation in neurosurgical ICU patients, potentially guiding future pain management protocols.