An interventional study of Combined anaesthesia and General anaesthesia in Gall Stone Disease and Polyp, sponsored by Lütfiye Nuri Burat Government Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-06-30.
Sponsored by Lütfiye Nuri Burat Government Hospital · Not applicable and Interventional
Pneumoperitoneum is formed with CO2 during laparoscopic abdominal operations. Effect of pneumoperitoneum on coagulation factors is not well known. In our study the investigators aimed to compare the general anesthesia(GA) and combined spinal-epidural anesthesia (CA) during laparoscopic cholecystectomy(LC) with effect on coagulation factors.
Fifty patients will be randomly assigned to either the Laparoscopic cholecystectomy under Combined anaesthesia (25 patients) or Laparoscopic cholecystectomy under general anaesthesia (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder.
Objective of study : The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy(LC).Laparoscopic cholecystectomies are usually performed under general anesthesia. Studies involving cholecystectomies with regional anesthesia recently published. During regional anesthesia pneumoperitoneum is performed with lower pressure(10mmHg CO2). Patients can not tolerate higher intraabdominally pressure. Thera are very few studies involving the effect of pneumoperitoneum on coagulation factors. In our study the investigators separate the patients into 2 groups. Group1:10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia ; Group2 : 10 mmHg pressure, laparoscopic cholecystectomy under Combined Spinal-Epidural Anesthesia The investigators performed standard conventional laparoscopic cholecystectomy procedure with 10mmHg pressure in both groups. The investigators aimed to investigate Prothrombin Time(PT), activated partial thromboplastin time(aPTT), thrombin time(TT), D-dimer and fibrinogen levels preoperative, postoperative 1st hour and 24th hour respectively.
346 studies on the registry are indexed under Gallstones; 46 are open to participants now.
This study's enrollment of 50 is below the median of 99 across 232 interventional studies indexed under Gallstones.
Browse Gallstones studies →Lütfiye Nuri Burat Government Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Laparoscopic cholecystectomy in general anaesthesia
Procedure: Combined anaesthesia
Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).
Procedure: General anaesthesia
Laparoscopic cholecystectomy under 10 mmHg pressure
Laparoscopic cholecystectomy under 10 mmHg pressure
Duration of Operation
group1 and group 2(Duration of Operation)
Time frame: up to 2 hours
Fibrinogen Level
A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation
Time frame: pre-operative
Fibrinogen Level
A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation
Time frame: Post-operative 1 st hour
Fibrinogen Level
A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation
Time frame: Post-operative 24th hour
PT(Prothrombin Time)
measures of the extrinsic pathway of coagulation
Time frame: pre-operative
PT(Prothrombin Time)
measures of the extrinsic pathway of coagulation
Time frame: Post-operative 1st hour
PT(Prothrombin Time)
measures of the extrinsic pathway of coagulation
Time frame: Post-operative 24th hours
D-Dimer
A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis
Time frame: pre-operative
D-Dimer
A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis
Time frame: Post-operative 1st hour
D-Dimer
A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis
Time frame: Post-operative 24th hours
aPTT(Activated Partial Thromboplastin Time)
measures of the intrinsic pathway of coagulation
Time frame: pre-operative
aPTT(Activated Partial Thromboplastin Time)
measures of the intrinsic pathway of coagulation
Time frame: Post-operative 1st hour
aPTT(Activated Partial Thromboplastin Time)
measures of the intrinsic pathway of coagulation
Time frame: Post-operative 24th hours
Thrombin Time(TT)
measures of the extrinsic and intrinsic pathway of coagulation
Time frame: pre-operative
Thrombin Time(TT)
measures of the extrinsic and intrinsic pathway of coagulation
Time frame: Post-operative 1st hour
Thrombin Time(TT)
measures of the extrinsic and intrinsic pathway of coagulation
Time frame: Post-operative 24th hours
| Milestone | Group 1 | Group 2 |
|---|---|---|
| Started | 25 | 25 |
| Completed | 25 | 25 |
| Not completed | 0 | 0 |
group1 and group 2(Duration of Operation)
| minutes | Group 1 | Group 2 |
|---|---|---|
| Duration of Operation | 54 (45 to 80) | 65 (53 to 92) |
A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation
| mg/dL | Group 1 | Group 2 |
|---|---|---|
| Fibrinogen Level | 219 (138 to 318) | 261 (87 to 395) |
A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation
| mg/dL | Group 1 | Group 2 |
|---|---|---|
| Fibrinogen Level | 253 (214 to 382) | 320 (171 to 495) |
A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation
| mg/dL | Group 1 | Group 2 |
|---|---|---|
| Fibrinogen Level | 352 (258 to 496) | 421 (250 to 760) |
measures of the extrinsic pathway of coagulation
| seconds | Group 1 | Group 2 |
|---|---|---|
| PT(Prothrombin Time) | 11.94 ± 0.64 | 11.78 ± 0.75 |
measures of the extrinsic pathway of coagulation
| seconds | Group 1 | Group 2 |
|---|---|---|
| PT(Prothrombin Time) | 12.1 ± 0.53 | 12.69 ± 0.84 |
measures of the extrinsic pathway of coagulation
| seconds | Group 1 | Group 2 |
|---|---|---|
| PT(Prothrombin Time) | 12.43 ± 0.86 | 13.63 ± 1.07 |
A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis
| mg/L | Group 1 | Group 2 |
|---|---|---|
| D-Dimer | 0.31 ± 0.08 | 0.34 ± 0.10 |
A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis
| mg/L | Group 1 | Group 2 |
|---|---|---|
| D-Dimer | 0.56 ± 0.22 | 1.06 ± 0.7 |
A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis
| mg/L | Group 1 | Group 2 |
|---|---|---|
| D-Dimer | 0.91 ± 0.34 | 1.61 ± 0.95 |
measures of the intrinsic pathway of coagulation
| seconds | Group 1 | Group 2 |
|---|---|---|
| aPTT(Activated Partial Thromboplastin Time) | 22.80 ± 1.48 | 25.0 ± 2.86 |
measures of the intrinsic pathway of coagulation
| seconds | Group 1 | Group 2 |
|---|---|---|
| aPTT(Activated Partial Thromboplastin Time) | 23.42 ± 1.54 | 25.25 ± 2.35 |
measures of the intrinsic pathway of coagulation
| seconds | Group 1 | Group 2 |
|---|---|---|
| aPTT(Activated Partial Thromboplastin Time) | 24.54 ± 2.16 | 26.92 ± 2.92 |
measures of the extrinsic and intrinsic pathway of coagulation
| seconds | Group 1 | Group 2 |
|---|---|---|
| Thrombin Time(TT) | 19.88 ± 1.58 | 20.57 ± 2.12 |
measures of the extrinsic and intrinsic pathway of coagulation
| seconds | Group 1 | Group 2 |
|---|---|---|
| Thrombin Time(TT) | 17.78 ± 0.74 | 17.61 ± 1.02 |
measures of the extrinsic and intrinsic pathway of coagulation
| seconds | Group 1 | Group 2 |
|---|---|---|
| Thrombin Time(TT) | 16.06 ± 1.05 | 16.01 ± 0.72 |
Collected over up to 24 weeks. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | — | 0/25 (0%) | 5/25 (20%) |
| Group 2 | — | 0/25 (0%) | 5/25 (20%) |
| Event | Group 1 | Group 2 |
|---|---|---|
| Nausea/vomitingGastrointestinal disorders | 4/25 | 1/25 |
| HypotensionCardiac disorders | 1/25 | 2/25 |
| urinary retensionRenal and urinary disorders | 0/25 | 1/25 |
| headacheNervous system disorders | 0/25 | 1/25 |
| Age, Continuous(years) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Median | 46 (19 to 69) | 52 (27 to 79) | 48 (19 to 79) |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Female | 20 | 19 | 39 |
| Male | 5 | 6 | 11 |
| Region of Enrollment(participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Turkey | 25 | 25 | 50 |
| ASA(American Society of Anesthesiologists ) scores(Scores on a scale(min:1 and max:6)) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Median | 1 (1 to 3) | 2 (1 to 3) | 2 (1 to 3) |
| BMI(kg/m^2) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Median | 28.1 ± 4.0 | 28.2 ± 3.5 | 28.15 ± 3.72 |
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Lütfiye Nuri Burat Government Hospital