Penehyclidine for PONV Prophylaxis After Strabismus Surgery
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|ClinicalTrials.gov Identifier: NCT04054479|
Recruitment Status : Completed
First Posted : August 13, 2019
Last Update Posted : December 17, 2019
Patients scheduled for elective strabismus surgery under general anesthesia in the First Affiliated Hospital of Nanjing Medical University will be included in this study.
Patients 1)ASA I or II, 2)aged 3-65 years, 3)scheduled for elective strabismus surgery under general anesthesia, will be included in the study. Patients 1)had prior PONV, 2)severe motion sickness, 3)a history of ophthalmic surgery, 4)had received drugs known to have antiemetic effects, will be excluded from the study.
The primary aim is to evaluate the prophylaxis effect of penehyclidine(a novel long acting selective anticholinergic agent developed in China) on postoperative nausea and vomiting after strabismus surgery. Secondary outcomes include the effect of PONV risk factors and surgical technique on PONV rank score, occurance of oculocardiac reflex, time to extubation.
|Condition or disease||Intervention/treatment||Phase|
|PONV||Drug: Penehyclidine Drug: normal saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||228 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effect of Penehyclidine on Postoperative Nausea and Vomiting After Strabismus Surgery|
|Actual Study Start Date :||July 20, 2019|
|Actual Primary Completion Date :||July 22, 2019|
|Actual Study Completion Date :||November 1, 2019|
Patients in this arm will receive penehyclidine after anesthesia intubation.
Patients receive penehyclidine 10μg/kg(up to 0.5mg, diluted with normal saline to 0.1mg/ml) after anesthesia intubation.
Placebo Comparator: Normal Saline
Patients in this arm will receive normal saline after anesthesia intubation.
Drug: normal saline
Patients receive 0.1ml/kg normal saline(up to 5ml) after anesthesia intubation.
- Incidence of PONV [ Time Frame: From extubation to 48 hours after surgery ]Occurance of postoperative nausea and vomiting after strabismus surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054479
|The First Affiliated Hospital of Nanjing Medical University|
|Nanjing, Jiangsu, China, 210029|
|Study Chair:||Zhengnian Ding, M.D.||The First Affiliated Hospital with Nanjing Medical University|
|Principal Investigator:||Xiaofei Cao, M.D.||The First Affiliated Hospital with Nanjing Medical University|
|Principal Investigator:||Ting Lu, M.M.||The First Affiliated Hospital with Nanjing Medical University|
|Principal Investigator:||Jiacheng Sun, M.M.||The First Affiliated Hospital with Nanjing Medical University|