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NCT Number: NCT06607029

Opioid-free Anesthesia Protocol for Neurosurgical Supratentorial Tumor Resection

Opioids have many side effects, such as constipation, urinary retention, itchy skin, respiratory depression, and postoperative nausea and vomiting. These side effects can lead to delayed recovery, longer hospital stays, and increased health care costs. Opioid-free anesthesia is the combination of anti-nociceptive drugs to block the different pathways involved in the transmission of nociceptive information, control pain, avoid opioid-related adverse reactions, and promote patient recovery. At present, opioid-free anesthesia is not widely used in craniocerebral surgery in neurosurgery, and the relevant clinical data are extensive. Therefore, the investigators urgently need to conduct a randomized controlled study to provide clinical evidence for the efficacy and safety of opioid-free anesthesia in neurosurgical patients.

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Key information

Conditions

Supratentorial Tumors Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Supratentorial Neoplasms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, China

Location status: Recruiting

About this study

Data sharing plan: The deidentified participant data reported in this study could be made available to researchers upon approval by the corresponding author (Dr. Ruquan Han, [email protected]) immediately after publication. The reasonable request should provide a formal protocol for database use that has been approved by the ethics institutions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled to undergo craniotomy for supratentorial tumors with general anesthesia;
  • 18 years≤age≤65 years;
  • American Society of Anesthesiologists (ASA) physical status of I to III;
  • Signed informed consent.

Exclusion criteria

  • Patients with a body mass index (BMI)≥35 kg/m2;
  • Patients with severe hepatic and renal insufficiency;
  • Patients with cognitive dysfunction, aphasia and other states that do not cooperate with the assessment;
  • Preoperative magnetic resonance imaging of the head showed midline displacement >5 mm;
  • Patients undergoing electrophysiological monitoring during surgery;
  • Pregnant or lactating patients.

Treatment and study plan

the opioid-based control group

Drug

Intraoperative analgesia will be administered with conventional opioid drugs such as sufentanil and remifentanil.

the opioid-free anesthesia group

Drug

The patients will be administered with an opioid-free strategy during surgery. The investigator will use esketamine, dexmetopidine, and local anesthesia to control perioperative pain.

Primary outcomes

  1. the quality of recovery-15(QoR-15) score on the second day after surgery

    Time frame: on the second day after surgery

    Quality of Recovery-15(QoR-15) score, as a tool to evaluate recovery quality during perioperative period. The QoR-15 scale was used to assess patients' postoperative recovery. Each item is scored on a 10-point scale, from 0 (worst recovery) to 150 (best recovery).

Secondary outcomes

  1. The QoR-15 score on the 5th day after surgery

    Time frame: on the 5th day after surgery

  2. The incidence of nausea and vomiting within 48 hours after surgery

    Time frame: 48 hours after surgery

  3. The NRS pain score on the second and 5th days after surgery

    Time frame: on the second and 5th days after surgery

  4. The sleep quality on the second and 5th days after surgery

    Time frame: on the second and 5th days after surgery

  5. The incidence of chronic pain at 3 and 6 months after surgery

    Time frame: at 3 and 6 months after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Han

CONTACT

[email protected]

010-59976660

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Opioid-free Anesthesia Protocol on the Quality of Recovery After Neurosurgical Supratentorial Tumor Resection: A Randomized, Controlled, Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 23, 2024
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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