Standard Carbon Dioxide Gas Versus Heated Humidified Gas in Gynaecological Laparoscopy

Heated Humidified Carbon Dioxide in Gynaecological Laparoscopic Surgery Clinical Trial

Official title:

The Effects of Using Heated Humidified Carbon Dioxide Gas on Post Operative Pain Scores, Nausea and Analgesic Requirements in Patients Undergoing Gynaecological Laparoscopy: a Randomised Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02319902
• Other study ID #: 14SURN0015
• Status: Recruiting
• Phase: N/A
• First received: December 14, 2014
• Last updated: December 14, 2014
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: Royal Surrey County Hospital
• Contact: Fevzi Shakir, MBBS BSc MRCOG
• Email: fevzi[@]doctors.org.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To establish if heated humidified carbon dioxide gas improves pain scores as well as nausea and analgesic requirements in post operative patients compared to standard cold carbon dioxide.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years of age

• Patients planned to undergo laparoscopy for minor procedures such as endometriosis, adhesions, ovarian cystectomies, bilateral salpingoophorectomy, tubal ligation and sterilisation will be invited to participate in the trial.

• Capacity to consent

Exclusion Criteria:

• Patients unable to speak English

• Patients unable to give consent

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heated Humidified Carbon Dioxide in Gynaecological Laparoscopic Surgery

Intervention

Device:
• Standard cold carbon dioxide gas
Use of standard cold carbon dioxide gas in laparoscopic gynaecological surgery.
• Heated humidified carbon dioxide gas
Use of the Fischer and Paykel heated humidification system for laparoscopic gynaecological surgery.

Locations

Country	Name	City	State
United Kingdom	Royal Surrey County Hospital NHS Trust	Guildford	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Fevzi Shakir

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder tip pain	Shoulder tip pain recorded as a visual analogue scale from 1-10, 8 hours post surgery compared to baseline	8 hours	No
Secondary	General abdominal pain, nausea, vomiting and analgesia requirements	General abdominal pain, nausea, vomiting and analgesia requirements 8 hours post surgery compared to baseline	8 hours	No
Secondary	Shoulder tip pain, general abdominal pain, nausea, vomiting.	Shoulder tip pain, general abdominal pain, nausea, vomiting over a 7 day period compared to baseline	7 days	No