NCT03472209

Brief Summary

We aimed to evaluate the different ETCO2 levels (with the help of ultrasonographic optic nerve sheath diameter) in preventing gynecological laparoscopic surgeons' postoperative nausea induced by intracranial pressure change due to pneumoperitoneum and trandelenburg position.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

1.3 years

First QC Date

March 14, 2018

Last Update Submit

November 5, 2019

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperative Nausea and VomitingGynecological Laparoscopic SurgeryEnd-tidal carbon dioxide

Outcome Measures

Primary Outcomes (1)

  • EtCO2

    End tidal carbondioxide

    During the operation (in 10 minutes interval)

Study Arms (2)

Group A

ETCO2=26-35 mmHg

Group B

ETCO2=36-45 mmHg

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with gynecological laparoscopic surgery

You may qualify if:

  • age, ASA I / II, BMI: 18-33 kg/m2, operation time: 50-130 min., gynecological laparoscopy

You may not qualify if:

  • In previous operations, Patients with postoperative nausea-vomiting (PONV) history, Smoking, Vehicle stays, Liver and kidney dysfunction, Abnormal fluid electrolyte balance, Gastrointestinal system disease, Preoperative antiemetic drug use, Cerebral disease,dysrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karadeniz Teknik Universitesi

Trabzon, 61080, Turkey (Türkiye)

RECRUITING

Karadeniz Technical University, Dept Obs and Gyn / Anestesiology

Trabzon, Turkey (Türkiye)

NOT YET RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Officials

  • Ahmet Besir, MD

    Karadeniz Teknit Üniversitesi Tıp Fakültesi

    STUDY CHAIR

Central Study Contacts

Ahmet Besir

CONTACT

+90 4623775398ahmetbesir61@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 14, 2018

First Posted

March 21, 2018

Study Start

January 22, 2018

Primary Completion

May 15, 2019

Study Completion

November 1, 2020

Last Updated

November 6, 2019

Record last verified: 2019-11

Locations

TU(2)