Menu
Not yet recruiting NCT06473194

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

No phase Interventional Anesthesia Complication Physiological Parameter

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: general anesthesia drug (like Propofol, esmeron, and ketamin, .effects of pneumoperitoneum.
Who it may be relevant to
Registry conditions: Anesthesia Complication, Physiological Parameter. Basic parameters: 20 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Physiological and Biochemical Effects of Laparoscopic Anesthesia and Surgery

Overview

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.

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)

Interventions

  • 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

Primary outcome measures

  • blood pressure. [Time frame: 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]
  • blood sugar, should measured and assessed with different groups [Time frame: 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]
  • 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]
Secondary outcome measures (1)
  • measurement of body weight [Time frame: measured preoperative period by 5 minute and post-operative during 15 minute]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • emergency condition
  • patient with cardiovascular disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06473194 · physiological measurement

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗