241 Huaihai West Road, Xuhui District, Shanghai
Shanghai, Shanghai Municipality, 200000, China
NCT Number: NCT06458400
This was a single-center, randomized, open-label, controlled exploratory study conducted in Chinese patients. The study planned to enroll Chinese patients to evaluate the efficacy and safety of tegileridine and oliceridine injection in the treatment of postoperative pain.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 4
Shanghai, Shanghai Municipality, 200000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
single dose+PCA dose
single dose+PCA dose
single dose+PCA dose
Time frame: during the first 24 hours after starting a loading dose of test drug infusion
"resting pain score" is assessed by Numeric Rating Scale, range 0-10, 0=no pain and 10 = worst imaginable pain, from 0 to 0 means worse pain
Time frame: Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose
Resting-state pain and exercise-state pain intensity are assessed by Numeric Rating Scale, range 0-10, 0=no pain and 10 = worst imaginable pain, from 0 to 0 means worse pain
Time frame: Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose
"exercise-state pain score" is assessed by Numeric Rating Scale, range 0-10, 0=no pain and
Time frame: 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose
Time-weighted sum of resting and moving state pain relief scores
Time frame: from 0-24 hours after the first loading dose
the percentage of patients receiving rescue analgesia
Time frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 months.
length out of bed
Time frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 months.
postoperative length of hospital stay
Time frame: the first 24 hours after surgery
incidence rate of PONV
Time frame: the first 24 hours after surgery
respiratory depression is defined as respiratory rate < 8 and/or SpO2<90%
Time frame: the first 24 hours after surgery
satisfaction evaluation using 0-100 scale
Time frame: the first 24 hours after surgery
Time frame: the first 24 hours after surgery
Yuwei Qiu
Other
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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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