This Study Assess Some Physiological Parameters, Blood Picture, and Hemodynamic Parameters, Blood Pressure, Respiratory Assess by SPO2, During Different Periods in Laparoscopic Surgery (laparoscopy)

June 21, 2024 updated by: Mohammed Abdulhameed

Physiological and Biochemical Effects of Laparoscopic Anesthesia and Surgery

Laparoscopic surgery is widely used now. These benefits included many items, e.g. reducing post-operative pain, cosmetic the result was improved, and the patient also had more satisfaction for the patient and reduced hospital stay. This surgery involved insufflation of gas into the peritoneal cavity, producing pneumoperitoneum, and causing an increase in intra-abdominal pressure. The raised intraabdominal pressure of the pneumoperitoneum, the patient's position alteration, and the absorption of carbon dioxide into the abdomen have a direct effect on causing a change in physiology, especially in the cardiovascular and respiratory systems. These effects, as well as a direct effect of gas insufflation, may have significant effects on the patient especially if the patient has a comorbidity or is elderly.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this study was to assess the technique used in laparoscopic surgery and their associated complications, including some hematological parameters, (these include blood pictures and liver enzymes), respiratory, (including the inspired and expired tidal volume, oxygen saturation, airway pressure, plateau pressure, and use of PEEP) cardiovascular system (including the systolic, diastolic, and mean blood pressure, heart rate)

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. elective abdominal surgery
  2. a healthy, fit person
  3. use of general anesthetics
  4. use of pneumoperitoneum and CO2 insufflation

Exclusion Criteria:

  1. emergency condition
  2. patient with cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: age , gender
group according to age and according to gender
Procedure: general anesthesia drug (like Propofol, esmeron, and ketamin, .effects of pneumoperitoneum
this research will involve the selection of elective cases with ASA class I or II and assessment of patients with respiratory cardiovascular parameters and hematology perioperative
Other Names:
  • monitoring in anesthesia to asses hemodynamic parameter includes blood pressure, pulse rate, and SPO2, compared with biochemical blood sugar, liver enzyme, respiratory alteration by end-tidal CO2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure.
Time Frame: during preoperative, 5 minute, intraoperative every five minute with post operative read after one hour
blood pressure in mmHg, pulse rate in beat per minute
during preoperative, 5 minute, intraoperative every five minute with post operative read after one hour
AST and ALT liver enzymes were measured, by blood samples taken intravenously in the perioperative period
Time Frame: 5 minute pre-operation and 5 minute postoperative
in unit/liter
5 minute pre-operation and 5 minute postoperative
blood sugar, should measured and assessed with different groups
Time Frame: 5 minute during pre-operative and 15 minute post- operative period
blood sugar in mg/dl
5 minute during pre-operative and 15 minute post- operative period
end-tidal Co2, measured and compared statistically with other parameter
Time Frame: perioperatively every 5 minute
End-tidal Co2 in CMH2O
perioperatively every 5 minute
pulse rate measured continuously during intra-operative and compared with other hemodynamic parameter
Time Frame: 5 minute during preoperative, and continue every 5 minute in perioperatively
beat per minute (BPM)
5 minute during preoperative, and continue every 5 minute in perioperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of body weight
Time Frame: measured preoperative period by 5 minute and post-operative during 15 minute
in Kg
measured preoperative period by 5 minute and post-operative during 15 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohammed Abdulhameed

Investigators

  • Study Director: hussam Mu. Kareem, PHD, Ministry of health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

June 1, 2024

First Submitted That Met QC Criteria

June 21, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 21, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • physiological measurement

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

after approval and acceptance these data would be available soon

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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