Analgesia, Patient-Controlled
Conditions
Brief summary
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.
Interventions
The PCA pumps contain sufentanil . And the pump is connected to participants intravenously .
DRUGsubcutaneous sufentanil
The PCA pumps contain sufentanil. And the pump is connected to participants subcutaneously.
The PCA pumps contain hydromorphone. And the pump is connected to participants intravenously .
DRUGsubcutaneous hydromorphone
The PCA pumps contain hydromorphone. And the pump is connected to participants subcutaneously.
DRUGintravenous sufentanil and dexmedetomidine
The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants intravenously .
DRUGsubcutaneous sufentanil and dexmedetomidine
The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants subcutaneously.
DRUGintravenous hydromorphone and dexmedetomidine
The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants intravenously.
DRUGsubcutaneous hydromorphone and dexmedetomidine
The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants subcutaneously
Sponsors
Jun Wang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale of Comfort level | 48 hours after the use of PCA. | The participants' comfort level of the PCA.0 means extremely comfort, 10 means extremely discomfort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ramsay sedation score | 6hours,12hours,24hours and 48 hours after the use of PCA. | To evaluate the degree of sedation. |
| The degree of nausea | 6hours,12hours,24hours and 48 hours after the use of PCA. | 0 means no nausea and vomiting,1 means only nausea,2means nausea and vomiting . |
| The degree of dizziness | 6hours,12hours,24hours and 48 hours after the use of PCA. | 0 means no dizziness,1 means the time of dizziness less than 2 hours,2 means the time of dizziness more than 2 hours. |
| Pupil diameter | 6hours,12hours,24hours and 48 hours after the use of PCA. | The average diameter of both pupils measuring by pupil pen. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh sleep quality index | 1 day before the surgery,1 month after the surgery. | The quality of sleep. |
Countries
China
Outcome results
None listed