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Comparison of Ondansetron and PC6 acupressure point on postoperative nausea and vomiting in patients, undergone elective cesarean section in 2016; a randomized clinical trial

Protocol summary

Summary
The aim of this randomized triple blind research is to compare Ondansetron and acupressure effects on nausea and vomiting after elective cesarean. Inclusion criteria are including the age range of 18 to 45 years, elective cesarean, being NPO 8 to 12 hours before surgery, lack of digestive and cardiovascular diseases, not taking immunosuppressive drugs, stability of hemodynamic condition, and American Society of Anesthesiologists classes I and II patients. Exclusion criteria are including lack of desire to cooperation in the study, change in surgery trend, outbreak of uncommon and unexpected problem, severe nausea and vomiting according to anesthesiologist’s diagnosis, and the weight more than 100 kg and less than 50 kg. The research population is female patients after elective cesarean in a total of 120 people. In this study, Ondansetron and acupressure would be used after clamping umbilical cord. First, the patients will be classified into 2 equal groups with randomized block allocation, 4 mg of Ondansetron will be prescribed for Ondansetron group, and a bracelet will be fastened without any pressure, 2 mg of distilled water will be prescribed for acupressure group, and a bracelet will be fastened with pressure. During the surgery, the continuous monitoring of heart rate will be performed. The severity of nausea, outbreak and number of episodes of vomiting will be measured and compared during surgery, recovery, and 6 hours after surgery in female surgical ward.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201603155596N3
Registration date: 2016-04-12, 1395/01/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-04-12, 1395/01/24
Registrant information
Name
Nasrin Galehdar
Name of organization / entity
Lorestan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 66142099714
Email address
galehdar.n@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research and technology of Lorestan University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Ondansetron and PC6 acupressure point on postoperative nausea and vomiting in patients, undergone elective cesarean section in 2016; a randomized clinical trial
Public title
Comparative effect of Ondansetron and acupressure on nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: elective cesarean; being NPO 8 to 12 hours before surgery; being NPO 6 hours after surgery; lack of symptomatic digestive disease; lack of motion sickness; lack of dizziness; lack of cardiovascular disease; lack of pulmonary disease; lack of middle ear disease; lack of diabetes; lack of infectious disease; lack of fever; lack of hypertension; lack of lateral surgery except for cesarean; lack of carpal tunnel syndrome; not taking alcohol; not taking immunosuppressive drugs; lack of long or unusual bleeding; lack of hemoglobin level less than 10 mg/dl; not receiving drugs except for antibiotics and analgesics in form of Diclofenac suppository daily 6 hours after surgery; American Society of Anesthesiologists classes I and II patients; patients with mild diseases without any performance limitation; patients with controlled disease; controlled diabetes or hypertension without systemic effects; smoking without chronic obstructive pulmonary disease; mild obesity; pregnant women aged 18 to 45 years with 38 to 40 weeks pregnant; exclusion criteria: lack of desire to continue cooperation in each step of research; change in surgery trend such as needing to general anesthesia; outbreak of any problem and uncommon and unexpected complication; severe nausea and vomiting according to anesthesiologist’s diagnosis; emergency cesarean; having lateral surgery except for cesarean; the weight more than 100 kg and less than 50 kg.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Lorestan University of Medical Sciences
Street address
Khorramabad, Kilometer 5 of Khorramabad-Tehran road, Lorestam University of Medical Sciences, Pardis complex, Deputy of research and technology
City
Khorramabad
Postal code
Approval date
2016-03-08, 1394/12/18
Ethics committee reference number
LUMS.REC.1394.46

Health conditions studied

1

Description of health condition studied
Nausea and vomiting
ICD-10 code
r11
ICD-10 code description
Nausea and vomiting

Primary outcomes

1

Description
Nausea
Timepoint
During the surgery, recovery, and in female surgical ward till 6 hours after the surgery
Method of measurement
Using checklist, asking questions and visual scale criteria

Secondary outcomes

1

Description
Outbreak of vomiting
Timepoint
During the surgery, recovery, and in female surgical ward till 6 hours after the surgery
Method of measurement
Using checklist, asking questions and visual scale criteria

2

Description
Number of episodes of vomiting
Timepoint
During the surgery, recovery, and in female surgical ward till 6 hours after the surgery
Method of measurement
Using checklist, asking questions and visual scale criteria

Intervention groups

1

Description
Prescribing Ondansetron in elective cesarean patients after clamping umbilical cord
Category
Prevention

2

Description
Applying acupressure in elective cesarean patients after clamping umbilical cord
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Asali Hospital
Full name of responsible person
Dr. Nasrin Galehdar
Street address
City
Khorramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr. Morovat Taheri Kalani
Street address
Khorramabad, Kilometer 5 of Khorramabad-Tehran road, Lorestam University of Medical Sciences, Pardis complex, Deputy of research and technology
City
Khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr. Nasrin Galehdar
Position
Faculty member
Other areas of specialty/work
Street address
Khorramabad, Kilometer 5 of Khorramabad-Tehran road, Lorestam University of Medical Sciences, Pardis complex, Deputy of research and technology
City
Khorramabad
Postal code
Phone
+98 66 3340 9971
Fax
Email
galehdr_nas@yahoo.co.ingalehdar.n@lums.ac.irukstudy2008@live.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr. Nasrin Galehdar
Position
Ph.D of Nursing
Other areas of specialty/work
Street address
Khorramabad, Kilometer 5 of Khorramabad-Tehran road, Lorestam University of Medical Sciences, Pardis complex, Deputy of research and technology
City
Khorramabad
Postal code
Phone
+98 66 3340 9971
Fax
Email
galehdr_nas@yahoo.co.ingalehdar.n@lums.ac.irukstudy2008@live.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abouzar Mohammadi
Position
BSc. of Surgical Technology
Other areas of specialty/work
Street address
Kashan, Ghotb-e-ravandi blvd
City
Kashan
Postal code
Phone
00
Fax
Email
ukstudy2008@live.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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