Pneumoperitoneum and Gynecological Laparoscopic Surgery: An Observational Clinical Study

Completed

• Conditions: Laparoscopy

• Registration Number: NCT03159637
• Lead Sponsor: Assiut University

Brief Summary

Laparoscopic surgery is now widely established.Laparoscopic surgery involves insufflation of a gas (usually carbon dioxide) into the peritoneal cavity producing a pneumoperitoneum. The raised intra-abdominal pressure of the pneumoperitoneum, alteration in the patient's position and effects of carbon dioxide absorption cause changes in physiology, especially within the cardiovascular and respiratory systems.

Detailed Description

The study will be carried out after approval of the ethical committee of Faculty of Medicine, Assiut University. A full preoperative anesthetic assessment will be carried out. Particular attention to the cardiovascular and respiratory systems is essential because of potential effects of the pneumoperitoneum and patient position.

Study Timeline

• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-17
• Study First Posted: 2017-05-19
• Study Start: 2017-05-30
• Primary Completion: 2018-11-12
• Status Verified: 2018-12
• Study Completion: 2018-12-01
• Last Update Submitted: 2018-12-04
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Age range 18-50
2. ASA 1
3. Elective gynecological laparoscopic surgery

Exclusion Criteria

1. Severe ischemic or valvular heart disease
2. Increased intracranial pressure (e.g. Hydrocephalus, Cerebral tumor, Head injury)
3. Hepatic or renal impairment
4. Emergency surgery
5. Open surgery
6. Previous abdominal surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mean arterial blood pressure	within the duration of the operation	mean arterial blood pressure will be monitored at different times
Pulmonary function tests	within the first 24 hours	forced expiratory volume at one second

Secondary Outcome Measures

Name	Time	Method
PaO2	within the first 24 hours	PaO2 will be monitored at different times
Arterial to end-tidal PaCO2- difference	within the first 24 hours	Arterial to end-tidal PaCO2- difference will be monitored at different times
Analgesic requirement	within the first 24 hours	Analgesic requirement will be monitored at different times by special scale (VAS)
Postoperative nausea and vomiting	within the first 24 hours	Postoperative nausea and vomiting will be monitored at different times by special scale
Intra-abdominal pressure	within the first 24 hours	Intra-abdominal pressure by direct measurement and indirect by Foley´s catheter will be monitored at different times (Cm water)

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt