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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007499
Receipt No. R000008847
Scientific Title Safety and efficacy of preanesthetic H2 antagonist therapy for patients on oral rehydration therapy until 2 h before surgery
Date of disclosure of the study information 2012/03/14
Last modified on 2012/09/19

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Basic information
Public title Safety and efficacy of preanesthetic H2 antagonist therapy for patients on oral rehydration therapy until 2 h before surgery
Acronym Safety and efficacy of preanesthetic H2 antagonist therapy for patients on oral rehydration therapy until 2 h before surgery
Scientific Title Safety and efficacy of preanesthetic H2 antagonist therapy for patients on oral rehydration therapy until 2 h before surgery
Scientific Title:Acronym Safety and efficacy of preanesthetic H2 antagonist therapy for patients on oral rehydration therapy until 2 h before surgery
Region
Japan

Condition
Condition condition required surgery
Classification by specialty
Not applicable
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose is that we evaluate safety and efficacy of preanesthetic H2 antagonist therapy for patients on ORT until 2 h before surgery with measuring gastric fluid acidity, and volume of gastric contents.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes gastric volume and its pH after anesthesia induction
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients scheduled for elective surgery under general anesthesia
Key exclusion criteria We excluted patients with gastrointestienal obstruction, body mass index (BMI) of 35 kg/m2 or larger, renal dysfunction (a creatinine clearance of 20ml/min or lower or dialysis ), pregnancy, the inability to take food orally, receiving gastroesophageal surgery previously, and long-term H2 antagonist medication.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatou Kitayama
Organization Hirosaki University school of Medicine & Hospital
Division name Department of Anesthesiology
Zip code
Address Hontyo 53, Hirosaki, Aomori, 036-8562, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masatou Kitayama
Organization Hirosaki University school of Medicine & Hospital
Division name Department of Anesthesiology
Zip code
Address Hontyo 53, Hirosaki, Aomori, 036-8562, Japan
TEL
Homepage URL
Email

Sponsor
Institute Hirosaki University school of Medicine & Hospital
Institute
Department

Funding Source
Organization Hirosaki University school of Medicine & Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
There were no significant differences between the groups with respect to sex, age, height, weight, and BMI. Neither gastric volume nor pH differed between the groups - ORT 9.6 (8.2) ml and 5.6 (1.7), respectively, vs. standard fasting 8.5 (6.8) ml and 5.5 (1.7), respectively. There was no incidence of vomiting or aspiration in either group during the induction of anesthesia. These data suggest that ORT may not reduce gastric volume in patients receiving a preanesthetic H2 antagonist.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients were randomly assigned to the ORS or the fasting group. Patients in both groups were premedicated orally with roxatidine 75mg at 21:00 the night before surgery and 2h before induction of anesthesia. Following a meal on the day before surgery, patients in the ORS group were given 1,000ml (into the operating room at 11:00) or 1,500ml (into the operating room at 13:00) of ORS (OS-1; Otsuka Pharmaceutical Factory, Tokushima, Japan) and allowed to consume the solution until 2h before surgery. Patients in the fasting group started fasting at 21:00 the night before surgery.
After tracheal intubation, a gastric tube was placed into the stomach, and its position was verified by auscultation of the epigastrium during insufflations of air. Gastric fluid was obtained by aspiration using a 30 ml syringe while changing the patient's position (supine, Trendelenburg,and reverse Trendelenburg, and right and left 20 degree semilateral positions) and with insufflation of 30 ml air plus upper-abdominal massage. The volume of gastric contents was recorded as well as the pH value, measured with a pH meter with 0.01 pH unit precision over the entire pH range (Ecoscan pH5 pH6; Iuchi Seieido Co, Ltd, Osaka, Japan) that was calibrated each morning.

Management information
Registered date
2012 Year 03 Month 14 Day
Last modified on
2012 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008847

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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