Pneumoperitoneum and Gynecological Laparoscopic Surgery: An Observational Clinical Study

Study Overview
=================
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.

Official Title
-----------------
Impact Of Posture and Prolonged Pneumoperitoneum on Intra-Operative and Postoperative Outcomes During Gynecological Laparoscopic Surgery: An Observational Clinical Study

Conditions
-----------------
Laparoscopy

Intervention / Treatment
-----------------
* Procedure: Laparoscopic Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range 18-50 ASA 1 Elective gynecological laparoscopic surgery Exclusion Criteria: Severe ischemic or valvular heart disease Increased intracranial pressure (e.g. Hydrocephalus, Cerebral tumor, Head injury) Hepatic or renal impairment Emergency surgery Open surgery Previous abdominal surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Laparoscopic Surgery|Insufflation of a gas (carbon dioxide) into the peritoneal cavity producing a pneumoperitoneum will be done. The positioning of the patients in Trendelenburg position will be done. intraoperative and postoperative outcomes will be assesed|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean arterial blood pressure | mean arterial blood pressure will be monitored at different times | within the duration of the operation | 
| Pulmonary function tests | forced expiratory volume at one second | within the first 24 hours | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumoperitoneum, Trendelenburg position, intra-abdominal pressure