EICVPV: Effect of Intraoperative Crystalloid Volume on Postoperative Vomiting

• Sponsor: Aydin Adnan Menderes University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02177201
• Collaborator: (none)
• Enrollment: 160
• Locations: 2
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 80
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief Summary

Postoperative nausea and vomiting is very common in children undergone tonsillectomy and/or adenoidectomy. The purpose of this clinical trial is to evaluate the antiemetic effect of super-hydration with 0.9% saline in children undergoing specifically elective otorhinolaryngological surgery. Fluid intake reduces vomiting as seen following extended period of fasting that interrupts the perfusion in gut. Based on this knowledge, we hypothesized that administration of supplemental fluid would reduce the incidence of postoperative vomiting.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Vomiting	Other: Group 1; Other: Group 2	N/A

Detailed Description

At the initiation of the study, 160 patients we enrolled consecutively . Six of the patients were excluded according to the inclusion/exclusion criteria. Remaining one hundred fifty four were American Society of Anesthesia (ASA) I-II classified children , aged 2-15 yr, undergoing elective tonsillectomy, with or without adenoidectomy, under general anesthesia . Induction and maintenance of anesthesia were standardized with fentanyl, lidocaine, rocuronium and sevoflurane in nitrous oxide (N(2)O). Subjects were assigned to two groups administered with saline solution (%0.9 saline) at different rates; either 10 ml/kg/h or 20ml/kg/h delivery arms.

Study Design

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Effect of Intravenous Crystalloid Volume on Postoperative Nausea and Vomiting After Tonsillectomy and/or Adenoidectomy: a Prospective, Randomized, Controlled Study
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Group 1 intravenous administration of 10 ml/kg/h 0.9% saline solution	Other: Group 1; Intravenous access was established and 10 ml/kg/h 0.9% saline solution was delivered following the induction of anesthesia and until the end of the operation.
Active Comparator: Group 2 intravenous administration of 20 ml/kg/h 0.9% saline solution	Other: Group 2; Intravenous access was established and 20 ml/kg/h 0.9% saline solution was delivered following the induction of anesthesia and until the end of the operation.

Outcome Measures

Primary Outcome Measures

1. Postoperative Vomiting [First 24 hours postoperative]

   Presence of at least one episode of vomiting within the first 24 hours of postoperative is positive for definition

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:ASA physical status I or II

• Age 2-15 yr

• Scheduled for elective tonsillectomy and/or adenotonsillectomy

Exclusion Criteria:

• History of diabetes

• History of mental retardation

• Obesity (BMI = > 95th percentile for age and sex)

• Intake of antiemetic or psychoactive medication within 24 hours before surgery

• Known gastroesophageal reflux

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Adnan Menderes University Training and Research Hospital	Aydın		Turkey	09100
2	Adnan Menders University	Aydın		Turkey	09100

Sponsors and Collaborators

• Aydin Adnan Menderes University

Investigators

• Study Director: SİNAN YILMAZ, MD, Adnan Menderes University,Faculty of Medicine, Department of Anesthesia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SİNAN YILMAZ, Associate Professor, Aydin Adnan Menderes University
• ClinicalTrials.gov Identifier: NCT02177201
• Other Study ID Numbers: 2013/255
• First Posted: Jun 27, 2014
• Last Update Posted: Feb 1, 2016
• Last Verified: Aug 1, 2015

• Additional relevant MeSH terms: Vomiting; Postoperative Nausea and Vomiting

Study Results

Participant Flow

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Intravenous 10 ml/kg/h 0.9% saline solution	Intravenous 20 ml/kg/h 0.9% saline solution
Period Title: Overall Study
STARTED	80	80
COMPLETED	77	77
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Group 1	Group 2	Total
Arm/Group Description	Intravenous 10 ml/kg/h 0.9% saline solution	Intravenous 20 ml/kg/h 0.9% saline solution	Total of all reporting groups
Overall Participants	80	80	160
Age (Count of Participants)
<=18 years	80 100%	80 100%	160 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	40 50%	40 50%	80 50%
Male	40 50%	40 50%	80 50%
Region of Enrollment (participants) [Number]
Turkey	80 100%	80 100%	160 100%
Supplemental fluid administration for vomiting (participants) [Number]
Number [participants]	80 100%	80 100%	160 100%

Outcome Measures

1. Primary Outcome

Title	Postoperative Vomiting
Description	Presence of at least one episode of vomiting within the first 24 hours of postoperative is positive for definition
Time Frame	First 24 hours postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	10 ml/kg/h 0.9 %Saline Solution	20 ml/kg/h 0.9% Saline Solution
Arm/Group Description	Group 1, intravenous 10 ml/kg/h 0.9% saline solution , 0.9 % saline solution: After induction, IV access was established and children were randomly allocated to receive Group 1, 10 ml/kg/h 0.9% saline solution ;	Group 2, intravenous 20 ml/kg/h 0.9% saline solution 0.9 saline solution : After induction , IV access was established and children were randomly allocated to receive: 20 ml/kg/h 0.9% saline solution during intraoperatively
Measure Participants	77	77
vomiting	11 13.8%	9 11.3%
not vomiting	66 82.5%	68 85%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	10 ml/kg/h 0.9 %Saline Solution, 20 ml/kg/h 0.9% Saline Solution
	Comments	Null hypothesis: The antiemetic effect was not significantly different for two groups in this study
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	10 ml/kg/h 0.9 %Saline Solution, 20 ml/kg/h 0.9% Saline Solution
	Comments	77 patients was needed in each groups for an 20% effect size, 5% alpha and 80% statistical power for postoperative vomiting.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared, Corrected
	Comments

Adverse Events

Time Frame	No adverse event were detected for all participants in the first 24 hours.
Adverse Event Reporting Description	No adverse event were detected for all participants in the first 24 hours.
Arm/Group Title	Group 1 Intravenous 10ml/kg/h 0.9 %Saline Solution		Group 2 Intravenous 20ml/kg/h 0.9 %Saline Solution
Arm/Group Description	Group 1, intravenous 10 ml/kg/h 0.9% saline solution , After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 ml/kg/h 0.9% saline solution ; Group 2, 20 ml/kg/h 0.9% saline solution by intravenous during intraoperatively. In both groups no adverse events were observed.		Group 2, intravenous 20 ml/kg/h 0.9% saline solution. After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 ml/kg/h 0.9% saline solution ; Group 2, 20 ml/kg/h 0.9% saline solution by intravenous during intraoperatively. In both groups no adverse events were observed.
All Cause Mortality
	Group 1 Intravenous 10ml/kg/h 0.9 %Saline Solution		Group 2 Intravenous 20ml/kg/h 0.9 %Saline Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Group 1 Intravenous 10ml/kg/h 0.9 %Saline Solution		Group 2 Intravenous 20ml/kg/h 0.9 %Saline Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/77 (0%)		0/77 (0%)
Other (Not Including Serious) Adverse Events
	Group 1 Intravenous 10ml/kg/h 0.9 %Saline Solution		Group 2 Intravenous 20ml/kg/h 0.9 %Saline Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/77 (0%)		0/77 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.