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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04111328
• Other study ID #: 2019-191-2
• Status: Completed
• Phase: Phase 4
• Start date: October 8, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: July 2020
• Source: First Hospital of China Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Analgesia, Patient-Controlled

Intervention

Drug:
• intravenous sufentanil
The PCA pumps contain sufentanil . And the pump is connected to participants intravenously .
• subcutaneous sufentanil
The PCA pumps contain sufentanil. And the pump is connected to participants subcutaneously.
• intravenous hydromorphone
The PCA pumps contain hydromorphone. And the pump is connected to participants intravenously .
• subcutaneous hydromorphone
The PCA pumps contain hydromorphone. And the pump is connected to participants subcutaneously.
• intravenous sufentanil and dexmedetomidine
The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants intravenously .
• subcutaneous sufentanil and dexmedetomidine
The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants subcutaneously.
• intravenous hydromorphone and dexmedetomidine
The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants intravenously.
• subcutaneous hydromorphone and dexmedetomidine
The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants subcutaneously

Locations

Country	Name	City	State
China	The First Affiliated Hosipital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Jun Wang

Country where clinical trial is conducted

China, 

Outcome

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.