Gastrointestinal Dysfunction
Conditions
Brief summary
Gastrointestinal dysfunction is common in patients after major surgery, especially for neurosurgery. It was reported 80% of neurosurgery patients could be combined with gastrointestinal dysfunction, and it may relate to old age, surgery time, and factors of anesthesia and surgery. Meanwhile, postoperative constipation, nausea, and vomiting induced by gastrointestinal dysfunction may increase the intracranial bleeding. Oliceridine could activate mu opioid receptors without the interaction of (beta)arr2-muOR, and may reduce the gastrointestinal dysfunction, but a limited study has illustrated this topic. Thus, this study is conducted to explore whether oliceridine could reduce the gastrointestinal dysfunction vs. sufentanil in patients undergoing neurosurgery.
Interventions
DRUGExperimental: Oliceridine group
During the operation, both the induction and maintenance of anesthesia as well as the analgesic drugs were administered with oxilazide. The dosage and administration timing of the drugs were determined by the anesthesiologist.
DRUGActive Comparator: Classical opioid group
During the operation, both the induction and maintenance of anesthesia were achieved using sufentanil. The dosage and administration timing of the drugs were determined by the anesthesiologist.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing selective neurosurgical resection of craniocerebral tumors; * Age ≥ 18 years old; * American Society of Anesthesiologists (ASA) grade 1-3; * Sign the informed consent form.
Exclusion criteria
* Patients unable to complete scale assessment due to preoperative language dysfunction or communication impairment; * Patients with preoperative symptoms of posterior cranial nerve injury and who need to retain a tracheal tube; * Patients with insular, brainstem, or medullary lesions that may impair early postoperative recovery of consciousness; * Patients undergoing intracranial lesion resection via the transsphenoidal approach; * Patients with a history of previous abdominal surgery; * Patients with BMI \> 35.0 kg/m2; * Patients with liver or kidney dysfunction; * Patients with a history of allergic or adverse reactions to the test drug; * Patients with a history of drug abuse; * Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High risk rate of gastrointestinal dysfunction | Within 72 hours after the operation | The high-risk rate of postoperative gastrointestinal dysfunction was assessed using the Intake, feeling nauseated, emesis, physical examination, and duration of symptoms (I-FEED) scoring system. |
Outcome results
None listed