Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery

Sun Yat-sen University

Status and phase: Unknown; Phase 4

Conditions: Arteriovenous Malformation

Treatments: Drug: dexmedetomidine 2; Drug: dexmedetomidine 1; Drug: dexmedetomidine 3; Drug: Sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT02552459

FirstSunYetSen-jn2015

Details and patient eligibility

About

The purpose of this study is to determine effect of combined medication of sufentanil and dexmedetomidine in patient controlled analgesia after neurosurgery.

Full description

Sufentanil is a classical drug for postoperative analgesia. Dexmedetomidine is a commonly used α2-adrenergic receptor, and it helps provide sedation, analgesia and inhibition of sympathetic activation. The investigators propose to recruit 120 patients who is undergoing the arteriovenous malformation embolism operation in department of Neurosurgery. Patients will be randomly divided into 4 groups(control group, sufentanil and low dexmedetomidine dose group, sufentanil and middle dexmedetomidine dose group, sufentanil and high dexmedetomidine dose group), then the investigators select post-operative records to determine whether dexmedetomidine can take a positive role in neurosurgical analgesia.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. patients undergoing venous malformation embolization operation through general anesthesia.
2. aged 18-65 years old.
3. operating time varies 1-4h,and extubation after the operation.

Exclusion criteria

1. long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history.
2. known for dexmedetomidine or other drugs allergy in this study.
3. cannot communicate.
4. preoperative systolic blood pressure <90 mmHg, or the heart rate <50/min.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 4 patient groups

sufentanil

Active Comparator group

Description:

sufentanil 150μg，intravenous administration during the following 72 hours after operation.

Treatment:

Drug: Sufentanil

sufentanil&dexmedetomidine 1

Experimental group

Description:

sufentanil 150μg，dexmedetomidine 0.05μg/kg/h，intravenous administration during the following 72 hours after operation.

Treatment:

Drug: Sufentanil

Drug: dexmedetomidine 1

sufentani&dexmedetomidine 2

Experimental group

Description:

sufentanil 150μg，dexmedetomidine 0.1μg/kg/h，intravenous administration during the following 72 hours after operation.

Treatment:

Drug: Sufentanil

Drug: dexmedetomidine 2

sufentanil&dexmedetomidine 3

Experimental group

Description:

sufentanil 150μg，dexmedetomidine 0.15μg/kg/h ，intravenous administration during the following 72 hours after operation.

Treatment:

Drug: Sufentanil

Drug: dexmedetomidine 3