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NCT Number: NCT04111328

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

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.

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Key information

Conditions

Analgesia, Patient-Controlled Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hosipital of China Medical University

Shenyang, Liaoning, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intravenous sufentanil

Drug

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

Other names: SI

subcutaneous sufentanil

Drug

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

Other names: SS

intravenous hydromorphone

Drug

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

Other names: HI

subcutaneous hydromorphone

Drug

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

Other names: HS

intravenous sufentanil and dexmedetomidine

Drug

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

Other names: SDI

subcutaneous sufentanil and dexmedetomidine

Drug

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

Other names: SDS

intravenous hydromorphone and dexmedetomidine

Drug

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

Other names: HDI

subcutaneous hydromorphone and dexmedetomidine

Drug

The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants subcutaneously

Other names: HDS

Primary outcomes

  1. Visual Analogue Scale of Comfort level

    Time frame: 48 hours after the use of PCA.

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

Secondary outcomes

  1. Ramsay sedation score

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

    To evaluate the degree of sedation.

  2. The degree of nausea

    Time frame: 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

    Time frame: 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

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

    The average diameter of both pupils measuring by pupil pen.

Other outcomes

  1. Pittsburgh sleep quality index

    Time frame: 1 day before the surgery,1 month after the surgery.

    The quality of sleep.

Sponsors and collaborators

Lead sponsor

Jun Wang

Other

Registry information

Official study title

the Effect of Different Drugs and Infusion Ways on Degree of Comfort for Patients Undergoing Spinal Neoplasm Surgery

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 1, 2019
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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