An observational study in Postoperative Nausea and Vomiting, sponsored by Daegu Catholic University Medical Center. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-11-02.
Sponsored by Daegu Catholic University Medical Center · Observational
Nausea and vomiting after surgery are one of the complications that occur after general anesthesia, and the frequency is reported to range from 10% to 80% in the high-risk group. Several studies have introduced drugs and methods to prevent nausea and vomiting after surgery. Among them, midazolam administered before surgery is known to have anti-anxiolytic and sedative effects on the prevention of nausea and vomiting after surgery. It has also been reported to increase its effectiveness when administered with other antiemetic agents.
The purpose of this study is to compare the effects of administration of combination with midazolam and different antiemetic agents on the prevention of postoperative nausea and vomiting in high-risk patients.
This prospective study evaluates female, nonsmoking patients undergoing laparoscopic cholecystectomy. The patients are divided into those with and without postoperative nausea and vomiting. The purpose of this study is to compare and observe the effect of administration of midazolam and two different antiemetics on prevention of postoperative nausea and vomiting.
0.05mg/kg of midazolam is administered intravenously 10 minutes before surgery as a pretreatment. 0.3mg ramosetron is administered intravenously right before the end of surgery and 0.075mg palonosetron is administered intravenously immediately after induction of anesthesia. The incidence of PONV, severity of nausea, use of rescue antiemetics, and pain severity was evaluated at 2 hours, 24hours, and 48 hours after surgery.
638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.
This study's enrollment of 68 is below the median of 208 across 93 observational studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →Daegu Catholic University Medical Center is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
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female patients aged 20 to 65 with ASA physical status 1 or 2 undergoing laparoscopic cholecystectomy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with PONV after administration of midazolam 0.05mg/kg with ramosetron 0.3mg or palonosetron 0.075mg
Patients with no PONV after administration of midazolam 0.05mg/kg with ramosetron 0.3mg or palonosetron 0.075mg
percentage of patients receiving ramosetron or palonosetron in each groups
percentage of patients receiving ramosetron or palonosetron
Time frame: 48 hours after surgery
severity of postoperative nausea in PONV group
0 = none, 1 = mild, 2 = moderate, 3 = severe
Time frame: 48 hours after surgery
postoperative pain
numerical analog scale : 0 to 10
Time frame: 48 hours after surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2019 to primary completion in Jun 2020, 9 months.
Of 52 non-industry observational studies under Postoperative Nausea and Vomiting, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 37. This study's 9 months is below that.
Counting every sponsor, half of 52 studies reached it within 11 months; a quarter within 4 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Postoperative Nausea and Vomiting →
Daegu Catholic University Medical Center