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Evaluation of the Effect of Two Types of Fluid in the Recovery From Anaesthesia. Voluven 6% v Hartmanns

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01122459
First Posted: May 13, 2010
Last Update Posted: July 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Rotunda Hospital
  Purpose
Avoiding nausea and vomiting is one of the most important for patient comfort and satisfaction, and preventing unplanned overnight stays in hospital following surgery. Studies have shown that increased amounts of intravenous fluid during surgery prevent nausea and vomiting after operations. This effect lasted for up to 48 hours after the surgery. Other unpleasant side effects of dehydration that delay recovery including headaches and dizziness can be prevented with fluid treatment during the operation. It is unclear if this effect happens with all types of fluid. The investigators propose to examine the effect of 2 types of intravenous fluids on recovery from anaesthesia. Each group will be given a different fluid while using our usual anaesthetic technique. The investigators will ask questions about nausea and vomiting after surgery (primary outcomes), and other factors relating to patient comfort such as headache and dizziness (secondary outcomes)

Condition Intervention Phase
Postoperative Nausea and Vomiting Other: fluid administration Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of the Effects of Two Types of Fluid in the Recovery From Anaesthesia.

Resource links provided by NLM:


Further study details as provided by The Rotunda Hospital:

Primary Outcome Measures:
  • Incidence of nausea and vomiting [ Time Frame: 120 mins ]

Secondary Outcome Measures:
  • Incidence of Headache [ Time Frame: 30 mins ]
  • Incidence of headache [ Time Frame: 120 mins ]
  • Incidence of headache [ Time Frame: 24 hours ]
  • Incidence of headache [ Time Frame: 48 hours ]
  • Incidence of nausea and vomiting [ Time Frame: 30 mins ]
  • Incidence of nausea and vomiting [ Time Frame: 24 hours ]
  • Incidence of nausea and vomiting [ Time Frame: 48 hours ]
  • Incidence of sore throat [ Time Frame: 30 mins ]
  • Incidence of sore throat [ Time Frame: 120mins ]
  • Incidence of sore throat [ Time Frame: 24 hours ]
  • Incidence of sore throat [ Time Frame: 48 hours ]
  • Incidence of dizzyness [ Time Frame: 30 mins ]
  • Incidence of dizzyness [ Time Frame: 120 mins ]
  • Incidence of dizzyness [ Time Frame: 24 hours ]
  • Incidence of dizzyness [ Time Frame: 48 hours ]
  • Verbal analogue scale of general wellbeing [ Time Frame: 30 mins ]
  • Verbal analogue scale of general wellbeing [ Time Frame: 120 mins ]
  • Verbal analogue scale of general wellbeing [ Time Frame: 24 hours ]
  • Verbal analogue scale of general wellbeing [ Time Frame: 48 hours ]

Enrollment: 120
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hartmanns
These patients will receive Hartmanns during anaesthesia
Other: fluid administration
1.5mls/kg/hr fasting
Active Comparator: Voluven 6% Other: fluid administration
1.5mls/kg/hr fasting

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • American Society of Anaesthesiology classification 1 & 2
  • Minor laparoscopic gynaecological surgery
  • Age 18-45

Exclusion Criteria:

  • Age <18 or > 45
  • Cardio-respiratory disease
  • Obesity: BMI >30
  • Relevant drug allergy to medication used in the protocol
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122459


Locations
Ireland
Rotunda Hospital
Dublin, Ireland, 1
Sponsors and Collaborators
The Rotunda Hospital
  More Information

Responsible Party: Dr Conan McCaul, Rotunda Hospital/ University College Dublin
ClinicalTrials.gov Identifier: NCT01122459     History of Changes
Other Study ID Numbers: RotAnaesFluid1
First Submitted: May 11, 2010
First Posted: May 13, 2010
Last Update Posted: July 21, 2011
Last Verified: May 2010

Keywords provided by The Rotunda Hospital:
Perioperative intravenous fluids

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Nausea
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs