Anesthesia ComplicationlaparoscopyNCT06473194
This Study Assess Some Physiological Parameters, Blood Picture, and Hemodynamic Parameters, Blood Pressure, Respiratory Assess by SPO2, During Different Periods in Laparoscopic Surgery
A study testing general anesthesia drug (like Propofol, esmeron, and ketamin, .effects of pneumoperitoneum in people with Anesthesia Complication and Physiological Parameter, run by Mohammed Abdulhameed.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Complication, Physiological Parameter
- What is being tested?
- general anesthesia drug (like Propofol, esmeron, and ketamin, .effects of pneumoperitoneum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- elective abdominal surgery
- a healthy, fit person
- use of general anesthetics
- use of pneumoperitoneum and CO2 insufflation
Who cannot join
- emergency condition
- patient with cardiovascular disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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)
- Conditions
- Anesthesia Complication, Physiological Parameter
- Being tested
- general anesthesia drug (like Propofol, esmeron, and ketamin, .effects of pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesia drug (like Propofol, esmeron, and ketamin, .effects of pneumoperitoneumProcedure or surgery
Also called 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
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
| Study group | Role | What they receive |
|---|---|---|
| age , gender | Experimental | group according to age and according to gender Receives: Procedure: general anesthesia drug (like Propofol, esmeron, and ketamin, .effects of pneumoperitoneum |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure.
blood pressure in mmHg, pulse rate in beat per minute
Measured: 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
Measured: 5 minute pre-operation and 5 minute postoperative
blood sugar, should measured and assessed with different groups
blood sugar in mg/dl
Measured: 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
Measured: perioperatively every 5 minute
pulse rate measured continuously during intra-operative and compared with other hemodynamic parameter
beat per minute (BPM)
Measured: 5 minute during preoperative, and continue every 5 minute in perioperatively
Secondary outcomes (1)
measurement of body weight
in Kg
Measured: measured preoperative period by 5 minute and post-operative during 15 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anesthesia ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed Abdulhameed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammed Abdulhameed, Tunis University
- Investigators
- hussam Mu. Kareem, PHD, Study director, Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473194
- Sponsor's protocol ID
- physiological measurement
- Acronym
- laparoscopy
- Status last verified
- Jun 2024
- First submitted
- 1 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: after approval and acceptance these data would be available soon
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.
PubMed 25558633Bitkin 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.
PubMed 30158037Sen 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.
PubMed 26855512Crema 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.
PubMed 16186960Hasukic 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.
PubMed 15863986
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Biochemical Effects of Laparoscopic Anesthesia and Surgery
- ClinicalTrials.gov ID
- NCT06473194
- Acronym / sponsor ID
- laparoscopy / physiological measurement
- Conditions
- Anesthesia Complication, Physiological Parameter
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mohammed AbdulhameedUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| age , gender | Experimental | Procedure: general anesthesia drug (like Propofol, esmeron, and ketamin, .effects of pneumoperitoneumgroup according to age and according to gender |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- elective abdominal surgery
- a healthy, fit person
- use of general anesthetics
- use of pneumoperitoneum and CO2 insufflation
Key exclusion criteria (2 listed)
- emergency condition
- patient with cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| general anesthesia drug (like Propofol, esmeron, and ketamin, .effects of pneumoperitoneumAlso: 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 CO2this 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 | Procedure or surgery | age , gender |
Primary outcome
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
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
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
end-tidal Co2, measured and compared statistically with other parameter
Time frame: perioperatively every 5 minute
End-tidal Co2 in CMH2O
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)
1 secondary outcome
measurement of body weight
Time frame: measured preoperative period by 5 minute and post-operative during 15 minute
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Background: PubMed 25558633Celep 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.
- Background: PubMed 30158037Bitkin 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.
- Background: PubMed 26855512Sen 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.
- Background: PubMed 16186960Crema 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.
- Background: PubMed 15863986Hasukic 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.
- Individual participant dataSharing planned: No. after approval and acceptance these data would be available soon
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
hussam Mu. Kareem, PHD study director
Ministry of Health
Questions about this trial
What is this clinical trial studying?
A study testing general anesthesia drug (like Propofol, esmeron, and ketamin, .effects of pneumoperitoneum in people with Anesthesia Complication and Physiological Parameter, run by Mohammed Abdulhameed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Ab. younis, PHD (009647801870904, mohammedhameed330@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure. (time frame: during preoperative, 5 minute, intraoperative every five minute with post operative read after one hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06473194, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.