Trial Outcomes & Findings for Effect of Intraoperative Crystalloid Volume on Postoperative Vomiting (NCT NCT02177201)

NCT ID: NCT02177201

Last Updated: 2016-02-01

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 160 participants
• Primary outcome timeframe: First 24 hours postoperative
• Results posted on: 2016-02-01

Participant Flow

Participant milestones

Measure	Group 1 Intravenous 10 ml/kg/h 0.9% saline solution	Group 2 Intravenous 20 ml/kg/h 0.9% saline solution
Overall Study STARTED	80	80
Overall Study COMPLETED	77	77
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Intraoperative Crystalloid Volume on Postoperative Vomiting

Baseline characteristics by cohort

Measure	Group 1 n=80 Participants Intravenous 10 ml/kg/h 0.9% saline solution	Group 2 n=80 Participants Intravenous 20 ml/kg/h 0.9% saline solution	Total n=160 Participants Total of all reporting groups
Age, Categorical <=18 years	80 Participants n=93 Participants	80 Participants n=4 Participants	160 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	40 Participants n=93 Participants	40 Participants n=4 Participants	80 Participants n=27 Participants
Sex: Female, Male Male	40 Participants n=93 Participants	40 Participants n=4 Participants	80 Participants n=27 Participants
Region of Enrollment Turkey	80 participants n=93 Participants	80 participants n=4 Participants	160 participants n=27 Participants
Supplemental fluid administration for vomiting	80 participants n=93 Participants	80 participants n=4 Participants	160 participants n=27 Participants

PRIMARY outcome

Timeframe: First 24 hours postoperative

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

Outcome measures

Measure	10 ml/kg/h 0.9 %Saline Solution n=77 Participants 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 ;	20 ml/kg/h 0.9% Saline Solution n=77 Participants 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
Postoperative Vomiting vomiting	11 participants	9 participants
Postoperative Vomiting not vomiting	66 participants	68 participants

Adverse Events

Group 1 Intravenous 10ml/kg/h 0.9 %Saline Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2 Intravenous 20ml/kg/h 0.9 %Saline Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sinan Yılmaz

Adnan Menders University, Anesthesiology and Reanimation Department

Phone: +905055954374

Email: dr_snnylmz@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place