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

NCT06473194 | Not Yet Recruiting

• 1 other identifier: physiological measurement
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anesthesia Complication; Physiological Parameter

Outcome Measures

Primary Outcomes (5)

• blood pressure.

  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

  in unit/liter

  5 minute pre-operation and 5 minute postoperative

• blood sugar, should measured and assessed with different groups

  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

  End-tidal Co2 in CMH2O

  perioperatively every 5 minute

• pulse rate measured continuously during intra-operative and compared with other hemodynamic parameter

  beat per minute (BPM)

  5 minute during preoperative, and continue every 5 minute in perioperatively

Secondary Outcomes (1)

• measurement of body weight

  measured preoperative period by 5 minute and post-operative during 15 minute

Study Arms (1)

age , gender

EXPERIMENTAL

group according to age and according to gender

Procedure: general anesthesia drug (like Propofol, esmeron, and ketamin, .effects of pneumoperitoneum

Interventions

general anesthesia drug (like Propofol, esmeron, and ketamin, .effects of pneumoperitoneum PROCEDURE

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

Also known as: 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

age , gender

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• elective abdominal surgery
• a healthy, fit person
• use of general anesthetics
• use of pneumoperitoneum and CO2 insufflation

You may not qualify if:

• emergency condition
• patient with cardiovascular disease

Sponsors & Collaborators

• Mohammed Abdulhameed: lead

Related Publications (5)

• Celep RB, Kahramanca S, Ozsoy M, Azili C, Cetinkunar S, Hasdemir AO, Guzel H, Ozgehan G, Colhan I, Kucukpinar TH. Effects of intraabdominal pressure on mean platelet volume during laparoscopic cholecystectomy. Turk J Med Sci. 2014;44(3):360-4. doi: 10.3906/sag-1304-23.

  PMID: 25558633 BACKGROUND

• Bitkin A, Aydin M, Irkilata L, Keles M, Akgunes E, Ocak S, Atilla MK. Effect of Intra-abdominal Pressure Rise on Hematological Parameters in Laparoscopic Urologic Surgery. J Coll Physicians Surg Pak. 2018 Sep;28(9):699-702. doi: 10.29271/jcpsp.2018.09.699.

  PMID: 30158037 BACKGROUND

• Sen MC, Turkyilmaz Z, Sonmez K, Karabulut R, Kaya Z, Yenicesu I, Gursel T, Basaklar AC. The Effect of Carbon Dioxide Insufflation Applied at Different Pressures and Periods on Thrombotic Factors. Indian J Hematol Blood Transfus. 2016 Mar;32(1):87-91. doi: 10.1007/s12288-015-0517-2. Epub 2015 Feb 15.

  PMID: 26855512 BACKGROUND

• Crema E, Ribeiro EN, Hial AM, Alves Junior JT, Pastore R, Silva AA. Evaluation of the response of cortisol, corticotropin and blood platelets kinetics after laparoscopic and open cholecystectomy. Acta Cir Bras. 2005 Sep-Oct;20(5):364-7. doi: 10.1590/s0102-86502005000500005. Epub 2005 Sep 5.

  PMID: 16186960 BACKGROUND

• Hasukic S, Kosuta D, Muminhodzic K. Comparison of postoperative hepatic function between laparoscopic and open cholecystectomy. Med Princ Pract. 2005 May-Jun;14(3):147-50. doi: 10.1159/000084630.

  PMID: 15863986 BACKGROUND

MeSH Terms

Interventions

Rocuronium; Heart Rate; Oxygen Saturation

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Metabolism

Study Officials

• hussam Mu. Kareem, PHD

  Ministry of Health

  STUDY DIRECTOR

Central Study Contacts

Mohammed Ab. younis, PHD

CONTACT

009647801870904; mohammedhameed330@gmail.com

wissem H. HMIDA, PROFF.

CONTACT

+21698452331; hmidawissem@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: describe techniques of laparoscopic procedures. 2. Discuss complications and assessments of patients who undergo laparoscopic procedures. 3. to assess liver function and hematological effects due to laparoscopic surgery 4. cardiovascular and respiratory squeal due to laparoscopic complication is minor compared to open surgery and can be managed rapidly.

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 25, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share