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

NCT01122459 | Completed Phase 3 DMC

• 1 other identifier: RotAnaesFluid1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Postoperative Nausea and Vomiting

Keywords

Perioperative intravenous fluids

Outcome Measures

Primary Outcomes (1)

• Incidence of nausea and vomiting

  120 mins

Secondary Outcomes (19)

• Incidence of Headache

  30 mins

• Incidence of headache

  120 mins

• Incidence of headache

  24 hours

• Incidence of headache

  48 hours

• Incidence of nausea and vomiting

  30 mins

Study Arms (2)

Hartmanns

ACTIVE COMPARATOR

These patients will receive Hartmanns during anaesthesia

Other: fluid administration

Voluven 6%

ACTIVE COMPARATOR

Other: fluid administration

Interventions

fluid administration OTHER

1.5mls/kg/hr fasting

Hartmanns; Voluven 6%

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Age \<18 or \> 45
• Cardio-respiratory disease
• Obesity: BMI \>30
• Relevant drug allergy to medication used in the protocol

Sponsors & Collaborators

• The Rotunda Hospital: lead

Study Sites (1)

Rotunda Hospital

Dublin, Dublin, 1, Ireland

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Hypodermoclysis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Infusions, Subcutaneous; Infusions, Parenteral; Drug Administration Routes; Drug Therapy; Therapeutics; Fluid Therapy

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 13, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: July 21, 2011

Record last verified: 2010-05

Locations

IE (1)