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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:
Information provided by:
The Rotunda Hospital
ClinicalTrials.gov Identifier:
NCT01122459
First received: May 11, 2010
Last updated: July 20, 2011
Last verified: May 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by The Rotunda Hospital:

Primary Outcome Measures:
  • Incidence of nausea and vomiting [ Time Frame: 120 mins ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of Headache [ Time Frame: 30 mins ] [ Designated as safety issue: No ]
  • Incidence of headache [ Time Frame: 120 mins ] [ Designated as safety issue: No ]
  • Incidence of headache [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Incidence of headache [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Incidence of nausea and vomiting [ Time Frame: 30 mins ] [ Designated as safety issue: No ]
  • Incidence of nausea and vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Incidence of nausea and vomiting [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Incidence of sore throat [ Time Frame: 30 mins ] [ Designated as safety issue: No ]
  • Incidence of sore throat [ Time Frame: 120mins ] [ Designated as safety issue: No ]
  • Incidence of sore throat [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Incidence of sore throat [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Incidence of dizzyness [ Time Frame: 30 mins ] [ Designated as safety issue: No ]
  • Incidence of dizzyness [ Time Frame: 120 mins ] [ Designated as safety issue: No ]
  • Incidence of dizzyness [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Incidence of dizzyness [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Verbal analogue scale of general wellbeing [ Time Frame: 30 mins ] [ Designated as safety issue: No ]
  • Verbal analogue scale of general wellbeing [ Time Frame: 120 mins ] [ Designated as safety issue: No ]
  • Verbal analogue scale of general wellbeing [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Verbal analogue scale of general wellbeing [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122459

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

No publications provided

Responsible Party: Dr Conan McCaul, Rotunda Hospital/ University College Dublin
ClinicalTrials.gov Identifier: NCT01122459     History of Changes
Other Study ID Numbers: RotAnaesFluid1
Study First Received: May 11, 2010
Last Updated: July 20, 2011
Health Authority: Ireland: Research Ethics Committee

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013