A Phase 2 interventional study of saline solution in Postanesthetic Excitement and Cesarean Section, sponsored by Hospital Central "Dr. Ignacio Morones Prieto". Completed at 1 site in Mexico. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by Hospital Central "Dr. Ignacio Morones Prieto" · Phase 2, Interventional, and Treatment
Evaluate the efficiency of management with intravenous dexmedetomidine compared to intravenous ondansetron to achieve the disappearance of post-anesthetic shivering in a shorter time in the obstetric patient undergoing cesarean section under regional anesthesia.
Randomized clinical trial with 40 pregnant patients, between 18 and 45 years old with ASA (American Society of Anesthesiologist) II or III, undergoing scheduled or emergency cesarean section with regional anesthesia and who presented grade tremor 1 based on the BSAS (Bedside shivering assessment scale) scale, at the Hospital Central from San Luis Potosi, Mexico. The main objective of this study was to quantify the time that elapsed from the end of the administration of the medication until the disappearance of the tremor, which was measured in minutes; The evaluation of the disappearance, persistence or reappearance of the tremor was solely visual by the anesthesiology staff.
763 studies on the registry are indexed under Emergence Delirium; 241 are open to participants now.
This study's enrollment of 40 is below the median of 120 across 475 interventional studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Hospital Central "Dr. Ignacio Morones Prieto" is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0.3 mcg Kg-1 (actual weight) of dexmedetomidine IV in 20 mL of saline
Drug: saline solution
8 mg ondansetron IV in 20 mL saline
Drug: saline solution
20 mL of saline
Also known as: isotonic solution
Period of time
period of time in which post-anesthetic tremor is controlled from the moment of administration
Time frame: one hour
Adverse effects
To measure the frequencies of occurrence of adverse effects and changes in vital signs (heart rate, blood pressure, and temperature \[measured at the tympanic membrane\]) correlated with resolution of tremor.
Time frame: one hour
Plan to share: No — It might be useful for other researchers to expand their investigations, nevertheless, in this moment it seems completed this branch of investigation.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Hospital Central "Dr. Ignacio Morones Prieto"