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Trial record 70 of 667 for:    CARBON DIOXIDE AND arterial

Pneumoperitoneum and Gynecological Laparoscopic Surgery: An Observational Clinical Study

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ClinicalTrials.gov Identifier: NCT03159637
Recruitment Status : Completed
First Posted : May 19, 2017
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Sayed Kaoud Abd-Elshafy, 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.

Condition or disease Intervention/treatment
Laparoscopy Procedure: Laparoscopic Surgery

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.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact Of Posture and Prolonged Pneumoperitoneum on Intra-Operative and Postoperative Outcomes During Gynecological Laparoscopic Surgery: An Observational Clinical Study
Actual Study Start Date : May 30, 2017
Actual Primary Completion Date : November 12, 2018
Actual Study Completion Date : December 1, 2018

Intervention Details:
  • 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


Primary Outcome Measures :
  1. mean arterial blood pressure [ Time Frame: within the duration of the operation ]
    mean arterial blood pressure will be monitored at different times

  2. Pulmonary function tests [ Time Frame: within the first 24 hours ]
    forced expiratory volume at one second


Secondary Outcome Measures :
  1. PaO2 [ Time Frame: within the first 24 hours ]
    PaO2 will be monitored at different times

  2. Arterial to end-tidal PaCO2- difference [ Time Frame: within the first 24 hours ]
    Arterial to end-tidal PaCO2- difference will be monitored at different times

  3. Intra-abdominal pressure [ Time Frame: 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)

  4. Postoperative nausea and vomiting [ Time Frame: within the first 24 hours ]
    Postoperative nausea and vomiting will be monitored at different times by special scale

  5. Analgesic requirement [ Time Frame: within the first 24 hours ]
    Analgesic requirement will be monitored at different times by special scale (VAS)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female patients only
Sampling Method:   Non-Probability Sample
Study Population
female patients only
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159637


Locations
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Egypt
Faculty of Medicine
Assiut, Egypt
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Sayed K Abd-Elshafy, M.D Associate Profossor

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Responsible Party: Sayed Kaoud Abd-Elshafy, Associate Profossor, Assiut University
ClinicalTrials.gov Identifier: NCT03159637     History of Changes
Other Study ID Numbers: IRB000087698
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sayed Kaoud Abd-Elshafy, Assiut University:
Pneumoperitoneum
Trendelenburg position
intra-abdominal pressure
Additional relevant MeSH terms:
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Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases