S-ketamine Prevents Tibial Fracture-associated Postoperative Pain and Cognitive Dysfunction After Orthopedic Surgery in Patients: a Randomized Double-blind Controlled Trial
Sponsor study identifier
interventional
120
1 country
1
Study Start
December 15, 2020
Actual (reported)Primary Completion
November 15, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 15, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Purpose: To explore effects of S-ketamine on postoperative pain and cognitive dysfunction after tibial fracture and orthopedic surgery. To evaluate and examine the incidence of adverse effects with the purpose of selecting the optimum dose.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 15, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 17, 2020
Actual (reported)November 24, 2020
Actual (reported)December 15, 2020
Actual (reported)November 15, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 15, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Mechanical hyperalgesia threshold on the palms of feet
The mechanical hyperalgesia threshold was defined as the lowest force (g) necessary to bend a Von Frey filament, which was perceived to be painful by the patient and measured by Von Frey filament.
48 hours after surgery
Pain Score (NRS)
48 hours after surgery
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm
48 hours after surgery
Time of First Postoperative Analgesic Requirement
1 hour after surgery
Total Dose of First Postoperative Analgesic Requirement
1 hour after surgery
Cumulative Sufentanyl Consumption
48 hours after surgery
After the induction of anesthesia, normal saline is intravenously injected in a volume of 2ml, and then a continuous infusion of 20 ml/h normal saline until starting skin suture.
After the induction of anesthesia, S-ketamine is intravenously injected at 0.2mg/kg, and then a continuous infusion of 0.2mg/kg/h S-ketamine until starting skin suture.
After the induction of anesthesia, normal saline is intravenously injected in a volume of 2ml, and then a continuous infusion of 20ml/h normal saline until starting skin suture.
After the induction of anesthesia, S-ketamine is intravenously injected at 0.2mg/kg, and then a continuous infusion of 0.2mg/kg/h S-ketamine until starting skin suture.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Administration procedure
S-ketamine (low-dose)
The registry describes an administration procedure or treatment schedule. Actual exposure and doses are not established by this entry.
View registry recordAdministration procedure
S-ketamine (high-dose)
The registry describes an administration procedure or treatment schedule. Actual exposure and doses are not established by this entry.
View registry recordTianjin Medical University General Hospital
Tianjin, 300052, China
Zhang L, Terrando N, Xu ZZ, Bang S, Jordt SE, Maixner W, Serhan CN, Ji RR. Distinct Analgesic Actions of DHA and DHA-Derived Specialized Pro-Resolving Mediators on Post-operative Pain After Bone Fracture in Mice. Front Pharmacol. 2018 May 1;9:412. doi: 10.3389/fphar.2018.00412. eCollection 2018.
Cui W, Li Y, Wang Z, Song C, Yu Y, Wang G, Li J, Wang C, Zhang L. Spinal caspase-6 regulates AMPA receptor trafficking and dendritic spine plasticity through netrin-1 in postoperative pain after orthopedic surgery for tibial fracture in mice. Pain. 2021 Jan;162(1):124-134. doi: 10.1097/j.pain.0000000000002021.
Guolin Wang, MD
Tianjin Medical University General Hospital
First Submitted
November 17, 2020
First Posted
November 24, 2020
Study Start
December 15, 2020
Actual (reported)Primary Completion
November 15, 2021
Estimated (date passed)After the induction of anesthesia, S-ketamine is intravenously injected at 0.4mg/kg, and then a continuous infusion of 0.4mg/kg/h S-ketamine until starting skin suture.
After the induction of anesthesia, S-ketamine is intravenously injected at 0.4mg/kg, and then a continuous infusion of 0.4mg/kg/h S-ketamine until starting skin suture.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 15, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 13, 2021
Record last verified: 2021-08
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Source: ClinicalTrials.gov.
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