Analgesia, Patient-Controlled Clinical Trial
Official title:
the Effect of Different Drugs and Infusion Ways on Degree of Comfort for Patients Undergoing Spinal Neoplasm Surgery
Verified date | July 2020 |
Source | First Hospital of China Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 600 |
Est. completion date | October 30, 2020 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hosipital of China Medical University | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
Jun Wang |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pittsburgh sleep quality index | The quality of sleep. | 1 day before the surgery,1 month after the surgery. | |
Primary | Visual Analogue Scale of Comfort level | The participants' comfort level of the PCA."0" means extremely comfort, "10" means extremely discomfort. | 48 hours after the use of PCA. | |
Secondary | Ramsay sedation score | To evaluate the degree of sedation. | 6hours,12hours,24hours and 48 hours after the use of PCA. | |
Secondary | The degree of nausea | "0" means no nausea and vomiting,"1" means only nausea,"2"means nausea and vomiting . | 6hours,12hours,24hours and 48 hours after the use of PCA. | |
Secondary | 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. | 6hours,12hours,24hours and 48 hours after the use of PCA. | |
Secondary | Pupil diameter | The average diameter of both pupils measuring by pupil pen. | 6hours,12hours,24hours and 48 hours after the use of PCA. |
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