This investigation was planned to evaluate the effect of superhydration on reducing the incidence of postoperative nausea and vomiting after tonsillectomy surgery.
Design
This is a two arm parallel group randomized clinical trial with blinded postoperative care and outcome assessment in which 110 patients will be studied in 2 groups
Settings and conduct
This investigation will be performed in Besat Hospital, Hamadan. The person who care the patients and the person who analyze the data are blinded to group stratification. After induction of general anesthesia; infusion of the fluids will be started according to the patients' group. Incidence of nausea and vomiting and rescue antiemetic drug usage will be recorded at recovery and at 12 and 24 hours after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all of the ASA 1 (2-12yr) healthy children candidate for adenotonsillectomy
Exclusion criteria: diabetes, antiemetic or psychotic drug usage during previous 24 hours, gastroesophageal reflux
Intervention groups
Intervention group: Infusion of lactated Ringer 30 cc/kg during surgery
Control group: Infusion of lactated Ringer 10 cc/kg during surgery
Main outcome variables
Postoperative nausea and vomiting, dose of antiemetic drug used during the first 24 hours after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120118008768N9
Registration date:2019-03-17, 1397/12/26
Registration timing:registered_while_recruiting
Last update:2019-03-17, 1397/12/26
Update count:0
Registration date
2019-03-17, 1397/12/26
Registrant information
Name
Mahshid Nikooseresht
Name of organization / entity
Hamadan university of Medical Sciences, Faculty of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 81 3823 5383
Email address
nikooseresht@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-09, 1397/07/17
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of restrictive and liberal fluid therapy on Postoperative nausea and vomiting in pediatric tonsillectomy surgery
Public title
Evaluation of the effect of superhydration on postoperative nausea and vomiting after tonsillectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy children aged between 2-12 yr
Candidate for tonsillectomy
Exclusion criteria:
ِRefuse to sign the informed consent by the parents
history of diabetes mellitus
mental retardation
obesity (body mass index N95th percentile for age and sex
intake of antiemetic within 24 hours before surgery
intake of psychoactive medication within 24 hours before surgery
known gastroesophageal reflux.
Inaccessibility of patient for follow-up
Age
From 2 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with sealed envelope For this purpose 4 papers were prepared. The letter "I" for Internention was written on 2 papers and the letter "C" for Comparison was written on two another papers. All 4 sheets were placed in a drawer and for including each patient one sheet was pulled out. According to the letter on the sheet "I" or "C"; the patient was assigned to intervention (leg elevation) or control (supine position) group. All of the four sheets were re-turned to the drawer and this cycle will be continued to meet the calculated sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, the person who collects data and the person who analyzes the data are blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee of Ethics in Research, Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
65178
Approval date
2018-10-09, 1397/07/17
Ethics committee reference number
IR.UMSHA.REC.1397.467
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
postoperative nausea and vomiting
Timepoint
in recovery room, 12 hours and 24 hours after surgery
Method of measurement
question from patient or parents
Secondary outcomes
1
Description
Requested antiemetic dose in first 24 hours after surgery
Timepoint
Aّt first 24 hours after surgery
Method of measurement
Evaluation of patients file and recording in questionnaire
Intervention groups
1
Description
Intervention group: (superhydration) Ringer lactate infusion 30cc/kg at the time of operation
Category
Prevention
2
Description
Control group: Infusion of 10cc/kg Lactated Ringer during surgery
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Mahshid Nikooseresht
Street address
Shahid Motahari Blvd, Resalat Square, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6514845471
Phone
+98 81 3264 0050
Email
nikooseresht@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saiid Bashirian
Street address
Hamadan University of Medical Science, Shahid Fahmideh street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
65178
Phone
+98 81 3838 0717
Email
nikooseresht@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahshid Nikooseresht
Position
Associate Professor of Anesthsiology, Fellowship of Pain managenent