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

• Sponsor: Jun Wang (Other)
• Overall Status: Completed
• CT.gov ID: NCT04111328
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Arms: 8
• Actual Duration (Months): 12.7
• Patients Per Site Per Month: 47.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia, Patient-Controlled	Drug: intravenous sufentanil; Drug: subcutaneous sufentanil; Drug: intravenous hydromorphone; Drug: subcutaneous hydromorphone; Drug: intravenous sufentanil and dexmedetomidine; Drug: subcutaneous sufentanil and dexmedetomidine; Drug: intravenous hydromorphone and dexmedetomidine; Drug: subcutaneous hydromorphone and dexmedetomidine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: the Effect of Different Drugs and Infusion Ways on Degree of Comfort for Patients Undergoing Spinal Neoplasm Surgery
• Actual Study Start Date: Oct 8, 2019
• Actual Primary Completion Date: Sep 30, 2020
• Actual Study Completion Date: Oct 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sufentanil administration intravenously The dose of sufentanil for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9% normal saline (NS).The PCA pump is connected to the hand vein.The parameters were set as background dose 1.5 ml/h, PCA dose 1ml, locking time 15 min.	Drug: intravenous sufentanil; The PCA pumps contain sufentanil . And the pump is connected to participants intravenously .; Other Names: SI
Experimental: sufentanil administration subcutaneously The dose of sufentanil for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the deltoid subcutaneously.The parameters were set as background dose 1.5 ml/h, PCA dose 1 ml, locking time 15 min.	Drug: subcutaneous sufentanil; The PCA pumps contain sufentanil. And the pump is connected to participants subcutaneously.; Other Names: SS
Experimental: hydromorphone administration intravenously The dose of hydromorphone for patient-controlled analgesia is 0.2mg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the hand vein.The parameters were set as background dose 1.5 ml/h, PCA dose 1 ml, locking time 15 min.	Drug: intravenous hydromorphone; The PCA pumps contain hydromorphone. And the pump is connected to participants intravenously .; Other Names: HI
Experimental: hydromorphone administration subcutaneously The dose of hydromorphone for patient-controlled analgesia is 0.2mg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the deltoid subcutaneously.The parameters were set as background dose 1.5 ml/h, PCA dose 1 ml, locking time 15 min.	Drug: subcutaneous hydromorphone; The PCA pumps contain hydromorphone. And the pump is connected to participants subcutaneously.; Other Names: HS
Experimental: sufentanil and dexmedetomidine intravenously The dose of sufentanil, dexmedetomidine,for patient-controlled analgesia is 3.0μg/Kg, dissolving in 100ml 0.9% normal saline (NS).The PCA pump is connected to the hand vein.The parameters were set as background dose 1.5 ml/h, PCA dose 1ml, locking time 15 min.	Drug: intravenous sufentanil and dexmedetomidine; The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants intravenously .; Other Names: SDI
Experimental: sufentanil and dexmedetomidine subcutaneously The dose of sufentanil ,dexmedetomidine ,for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the deltoid subcutaneously.The parameters were set as background dose 1.5 ml/h, PCA dose 1 ml, locking time 15 min.	Drug: subcutaneous sufentanil and dexmedetomidine; The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants subcutaneously.; Other Names: SDS
Experimental: hydromorphone and dexmedetomidine intravenously The dose of hydromorphone for patient-controlled analgesia is 0.2mg/Kg ,dexmedetomidine ,for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the hand vein.The parameters were set as background dose 1.5ml/h, PCA dose 1ml, locking time 15 min.	Drug: intravenous hydromorphone and dexmedetomidine; The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants intravenously.; Other Names: HDI
Experimental: hydromorphone and dexmedetomidine subcutaneously The dose of hydromorphone for patient-controlled analgesia is 0.2mg/Kg ,dexmedetomidine ,for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the deltoid subcutaneously.The parameters were set as background dose 1.5ml/h, PCA dose 1 ml, locking time 15 min.	Drug: subcutaneous hydromorphone and dexmedetomidine; The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants subcutaneously; Other Names: HDS

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Ramsay sedation score [6hours,12hours,24hours and 48 hours after the use of PCA.]

   To evaluate the degree of sedation.

2. 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,"2"means nausea and vomiting .

3. 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.

4. Pupil diameter [6hours,12hours,24hours and 48 hours after the use of PCA.]

   The average diameter of both pupils measuring by pupil pen.

Other Outcome Measures

1. Pittsburgh sleep quality index [1 day before the surgery,1 month after the surgery.]

   The quality of sleep.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hosipital of China Medical University	Shenyang	Liaoning	China

Sponsors and Collaborators

• Jun Wang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jun Wang, Professor, First Hospital of China Medical University
• ClinicalTrials.gov Identifier: NCT04111328
• Other Study ID Numbers: 2019-191-2
• First Posted: Oct 1, 2019
• Last Update Posted: Feb 9, 2021
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Sufentanil; Dexmedetomidine; Dsuvia; Hydromorphone

Study Results

No Results Posted as of Feb 9, 2021