Clinical trial NCT06473194: This Study Assess Some Physiological Parameters, Blood Picture, and Hemodynamic Parameters, Blood Pressure, Respiratory Assess by SPO2, During Different Periods in Laparoscopic Surgery
Official title: Physiological and Biochemical Effects of Laparoscopic Anesthesia and Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anesthesia Complication
Physiological Parameter
Lead sponsor: Tunis University
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: blood pressure.
timeFrame: during preoperative, 5 minute, intraoperative every five minute with post operative read after one hour
measure: AST and ALT liver enzymes were measured, by blood samples taken intravenously in the perioperative period
timeFrame: 5 minute pre-operation and 5 minute postoperative
measure: blood sugar, should measured and assessed with different groups
timeFrame: 5 minute during pre-operative and 15 minute post- operative period
measure: end-tidal Co2, measured and compared statistically with other parameter
timeFrame: perioperatively every 5 minute
measure: pulse rate measured continuously during intra-operative and compared with other hemodynamic parameter
timeFrame: 5 minute during preoperative, and continue every 5 minute in perioperatively
Secondary outcomes:
measure: measurement of body weight
timeFrame: measured preoperative period by 5 minute and post-operative during 15 minute
Other outcomes:
Locations:
Study officials:
affiliation: Ministry of Health
name: hussam Mu. Kareem, PHD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.