the Effect of Different Drugs and Infusion Ways on Degree of Postoperative Comfort

Jun Wang600 enrolled

Overview

To explore the effect of different drugs and infusion ways on degree of postoperative comfort.Patients undergoing spinal neoplasm surgery receive different patient controlled analgesia(PCA) drugs postoperatively,one group is sufentanil,the other is hydromorphone. Then each drug group will be divided into two subgroups according to the infusion way,intravenously,subcutaneously. During the patient controlled analgesia period, patients' degree of comfort,pain score,sleep quality, the degree of side reaction will be recorded.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

600

Conditions

Analgesia, Patient-Controlled

Interventions

intravenous sufentanilDRUG

The PCA pumps contain sufentanil . And the pump is connected to participants intravenously .

subcutaneous sufentanilDRUG

The PCA pumps contain sufentanil. And the pump is connected to participants subcutaneously.

intravenous hydromorphoneDRUG

The PCA pumps contain hydromorphone. And the pump is connected to participants intravenously .

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status I or II . Exclusion Criteria: * history of severe heart, hepatic or renal disease, * history of chronic pain condition or opioid use, * body mass index (BMI) ≤18 or ≥30 kg/m2, * alcohol or drug abuse, * relevant drug allergy, * inability to properly describe postoperative pain, * inability to use PCA pump.

Locations (1)

The First Affiliated Hosipital of China Medical University

Shenyang, Liaoning, China

Outcomes

Primary Outcomes

Visual Analogue Scale of Comfort level

The participants' comfort level of the PCA."0" means extremely comfort, "10" means extremely discomfort.

Time frame: 48 hours after the use of PCA.

Secondary Outcomes

Ramsay sedation score

To evaluate the degree of sedation.

Time frame: 6hours,12hours,24hours and 48 hours after the use of PCA.

The degree of nausea

"0" means no nausea and vomiting,"1" means only nausea,"2"means nausea and vomiting .

Time frame: 6hours,12hours,24hours and 48 hours after the use of PCA.

The degree of dizziness

"0" means no dizziness,"1" means the time of dizziness less than 2 hours,"2" means the time of dizziness more than 2 hours.

Time frame: 6hours,12hours,24hours and 48 hours after the use of PCA.

Pupil diameter

The average diameter of both pupils measuring by pupil pen.

Time frame: 6hours,12hours,24hours and 48 hours after the use of PCA.

Data from ClinicalTrials.gov

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