Gall Stone Disease, Polyp
Conditions
Keywords
Combined anesthesia, General anesthesia, Laparoscopic cholecystectomy
Brief summary
The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer several advantages over general anesthesia. Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder. Intraoperative events related to combined anesthesia , postoperative complications, pain score and duration of operation time will record.
Detailed description
Objective of study : The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer several advantages over general anesthesia. Material and methods : Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder. Intraoperative events related to combined anesthesia : abdominal discomfortable, shoulder pain, abdominal pain, nausea, anxiety, dermatomal level of sensory blockade, respiratory depression. We compare between two group; shoulder pain, postoperative complications, pain score, duration of operation time and length of hospital stay. Fifty patients will select prospectively for LC, under low pressure (10 mm Hg) pneumoperitoneum and under combined anesthesia and general anesthesia. Spinal anaesthesia was performed at L1-L2 interspace using 2 ml of 0.5% (10 mg) hyperbaric Bupivacaine mixed with 0.5ml (25 micrograms) of Fentanyl. Epidural catheter was inserted at L1- L2 interspace too.
Interventions
PROCEDUREcombined anesthesia
Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy
PROCEDUREgeneral anesthesia
General anesthesia for laparoscopic cholecystectomy
Sponsors
Haseki Training and Research Hospital
Lütfiye Nuri Burat Government Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Gall stone disease, polyp
Exclusion criteria
* Gall bladder cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Operation | up to 2 hours | group 1:surgical operation time is 20 minutes minimum and maximum 55 minutes. Mean operation time 36.56 minutes group 2:surgical operation time is 24 minutes minimum and maximum 53 minutes. Mean operation time 30.75 minutes |
| Post-operative Shoulder Pain | from end of the operation to postoperative 3 days | Group 1 and Group 2 Post-operative shoulder pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Abdominal Pain 4th Hour | pain at postoperative 4th hour | VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. |
| Post-operative Abdominal Pain 6th Hour | pain at postoperative 6th hour | VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. |
| Post-operative Abdominal Pain 12th Hour | pain at postoperative 12th hour | VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. |
| Post-operative Abdominal Pain 24th Hour | pain at postoperative 24th hour | VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. |
| Duration of Anaesthesia | up to 2 hours | Group 1 minimum 42 minutes and maximum 83 minutes.mean duration of anaesthesia 60.17 and Group 2 minimum 45 minutes and maximum 82 minutes mean duration of anaesthesia 60.23 |
| Urinary Retention | from end of the operation to postoperative 1 day | Group 1 and Group 2 Urinary retention |
| Nausea/Vomiting | from end of the operation to postoperative 1 day | Group 1 and group 2 nausea/vomiting |
| Headache | from end of the operation to postoperative 3 days | Group 1 and Group 2 Headache |
| Intra-operative Shoulder Pain | during operation time, up to 2 hours | Group 1 and Group 2 Intra-operative shoulder pain |
| Post-operative Abdominal Pain 2nd Hour | pain at postoperative 2nd hour | VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
medical clinic
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Laparoscopic cholecystectomy in General Anesthesia
combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy | 25 |
| Group 2 Laparoscopic cholecystectomy in combined anesthesia (Spino epidural).
general anesthesia: General anesthesia for laparoscopic cholecystectomy | 24 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 13.38 | 45.5 years STANDARD_DEVIATION 13.6 | 46 years STANDARD_DEVIATION 13.35 |
| ASA (American Society of Anesthesiologists scores) | 1 units on a scale | 1 units on a scale | 1 units on a scale |
| BMI | 28.66 kg/m^2 STANDARD_DEVIATION 4.49 | 30.68 kg/m^2 STANDARD_DEVIATION 3.59 | 29.55 kg/m^2 STANDARD_DEVIATION 4.14 |
| Region of Enrollment Turkey | 25 participants | 24 participants | 49 participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 18 Participants | 18 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 25 | 16 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 |
Outcome results
Primary
Duration of Operation
group 1:surgical operation time is 20 minutes minimum and maximum 55 minutes. Mean operation time 36.56 minutes group 2:surgical operation time is 24 minutes minimum and maximum 53 minutes. Mean operation time 30.75 minutes
Time frame: up to 2 hours
Population: All patients have gall bladder disease who are between 18-90 years old.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Duration of Operation | 36.56 minutes | Standard Deviation 10.627 |
| Group 2 | Duration of Operation | 30.75 minutes | Standard Deviation 7.502 |
Primary
Post-operative Shoulder Pain
Group 1 and Group 2 Post-operative shoulder pain
Time frame: from end of the operation to postoperative 3 days
Population: All patients have gall bladder disease who are between 18-90 years old
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Post-operative Shoulder Pain | shoulder pain yes | 15 participants |
| Group 1 | Post-operative Shoulder Pain | shoulder pain no | 10 participants |
| Group 2 | Post-operative Shoulder Pain | shoulder pain yes | 6 participants |
| Group 2 | Post-operative Shoulder Pain | shoulder pain no | 18 participants |
Secondary
Duration of Anaesthesia
Group 1 minimum 42 minutes and maximum 83 minutes.mean duration of anaesthesia 60.17 and Group 2 minimum 45 minutes and maximum 82 minutes mean duration of anaesthesia 60.23
Time frame: up to 2 hours
Population: All patients have gall bladder disease who are between 18-90 years old.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Duration of Anaesthesia | 60.17 minutes | Standard Deviation 10.73 |
| Group 2 | Duration of Anaesthesia | 60.23 minutes | Standard Deviation 7.87 |
Secondary
Headache
Group 1 and Group 2 Headache
Time frame: from end of the operation to postoperative 3 days
Population: All patients have gall bladder disease who are between 18-90 years old.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Headache | headache yes | 0 participants |
| Group 1 | Headache | headache no | 25 participants |
| Group 2 | Headache | headache yes | 2 participants |
| Group 2 | Headache | headache no | 22 participants |
Secondary
Intra-operative Shoulder Pain
Group 1 and Group 2 Intra-operative shoulder pain
Time frame: during operation time, up to 2 hours
Population: All patients have gall bladder disease who are between 18-90 years old.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Intra-operative Shoulder Pain | shoulder pain yes | 0 participants |
| Group 1 | Intra-operative Shoulder Pain | shoulder pain no | 25 participants |
| Group 2 | Intra-operative Shoulder Pain | shoulder pain yes | 3 participants |
| Group 2 | Intra-operative Shoulder Pain | shoulder pain no | 21 participants |
Secondary
Nausea/Vomiting
Group 1 and group 2 nausea/vomiting
Time frame: from end of the operation to postoperative 1 day
Population: All patients have gall bladder disease who are between 18-90 years old.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Nausea/Vomiting | nausea/vomiting yes | 5 participants |
| Group 1 | Nausea/Vomiting | nausea/vomiting no | 20 participants |
| Group 2 | Nausea/Vomiting | nausea/vomiting yes | 1 participants |
| Group 2 | Nausea/Vomiting | nausea/vomiting no | 23 participants |
Secondary
Post-operative Abdominal Pain 12th Hour
VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
Time frame: pain at postoperative 12th hour
Population: All patients have gall bladder disease who are between 18-90 years old.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Post-operative Abdominal Pain 12th Hour | 3 units on a scale | Standard Deviation 0.72 |
| Group 2 | Post-operative Abdominal Pain 12th Hour | 1 units on a scale | Standard Deviation 0.46 |
Secondary
Post-operative Abdominal Pain 24th Hour
VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
Time frame: pain at postoperative 24th hour
Population: All patients have gall bladder disease who are between 18-90 years old.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Post-operative Abdominal Pain 24th Hour | 2 units on a scale | Standard Deviation 0.52 |
| Group 2 | Post-operative Abdominal Pain 24th Hour | 1 units on a scale | Standard Deviation 0.5 |
Secondary
Post-operative Abdominal Pain 2nd Hour
VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
Time frame: pain at postoperative 2nd hour
Population: All patients have gall bladder disease who are between 18-90 years old.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Post-operative Abdominal Pain 2nd Hour | 7 units on a scale | Standard Deviation 0.71 |
| Group 2 | Post-operative Abdominal Pain 2nd Hour | 1 units on a scale | Standard Deviation 0.51 |
Secondary
Post-operative Abdominal Pain 4th Hour
VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
Time frame: pain at postoperative 4th hour
Population: All patients have gall bladder disease who are between 18-90 years old.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Post-operative Abdominal Pain 4th Hour | 6 units on a scale | Standard Deviation 0.71 |
| Group 2 | Post-operative Abdominal Pain 4th Hour | 2 units on a scale | Standard Deviation 0.57 |
Secondary
Post-operative Abdominal Pain 6th Hour
VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.
Time frame: pain at postoperative 6th hour
Population: All patients have gall bladder disease who are between 18-90 years old.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Post-operative Abdominal Pain 6th Hour | 4 units on a scale | Standard Deviation 0.45 |
| Group 2 | Post-operative Abdominal Pain 6th Hour | 4 units on a scale | Standard Deviation 0.6 |
Secondary
Urinary Retention
Group 1 and Group 2 Urinary retention
Time frame: from end of the operation to postoperative 1 day
Population: All patients have gall bladder disease who are between 18-90 years old
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 | Urinary Retention | urinary retention yes | 0 participants |
| Group 1 | Urinary Retention | urinary retention no | 25 participants |
| Group 2 | Urinary Retention | urinary retention yes | 3 participants |
| Group 2 | Urinary Retention | urinary retention no | 21 participants |