Epidural AnesthesiaNCT04721054
Thoracic Epidural Versus General Anesthesia for Laparoscopic Cholecystectomy
A study testing Thoracic epidural effect on heart rate in Laparoscopic Cholecystectomy (bupivacaine and lignocaine) and general anesthesia effect on heart rate in Laparoscopic Cholecystectomy in people with Epidural Anesthesia and General Anesthesia, run by Armed Forces Hospital, Pakistan at 1 site in Pakistan.
Trial summary
Eighty two patients planned to undergo elective laparoscopic cholecystectomy were divided into two groups, T and G, randomly. In Group T all patients underwent laparoscopic cholecystectomy under thoracic epidural anesthesia with 12mlof 0.25% bupivacaine and 1% lignocaine plain whereas in group G all patients underwent… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Epidural Anesthesia, General Anesthesia
- What is being tested?
- Thoracic epidural effect on heart rate in Laparoscopic Cholecystectomy (bupivacaine and lignocaine) and general anesthesia effect on heart rate in Laparoscopic Cholecystectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2018to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients having ASA statusI-III
- age more than 18 years,
- both genders
- planned to undergo laparoscopic cholecystectomy
Who cannot join
- Patients who did not give consent,
- Allergic to local anesthetic
- Hemodynamically unstable,
- Pregnant, full stomach patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thoracic Epidural Versus General Anesthesia for Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Eighty two patients planned to undergo elective laparoscopic cholecystectomy were divided into two groups, T and G, randomly. In Group T all patients underwent laparoscopic cholecystectomy under thoracic epidural anesthesia with 12mlof 0.25% bupivacaine and 1% lignocaine plain whereas in group G all patients underwent surgery under general anesthesia. Intra-operative heart rate, mean arterial pressure (MAP) and post operative opioid consumption in first 24hrs were recorded as primary outcomes whereas presence or absence of respiratory complication and duration of hospital stay as secondary outcome.
- Conditions
- Epidural Anesthesia, General Anesthesia
- Being tested
- Thoracic epidural effect on heart rate in Laparoscopic Cholecystectomy (bupivacaine and lignocaine), general anesthesia effect on heart rate in Laparoscopic Cholecystectomy
- Keywords
- headache, blood pressure
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic epidural effect on heart rate in Laparoscopic Cholecystectomy (bupivacaine and lignocaine)Drug
Also called Thoracic epidural effect on mean arterial pressure in Laparoscopic Cholecystectomy
patients in epidural anesthesia were given epidural anesthesia and assessed for heart rate and mean arterial pressure
general anesthesia effect on heart rate in Laparoscopic CholecystectomyDrug
Also called general anesthesia effect on mean arterial pressure in Laparoscopic Cholecystectomy
patients in general anesthesia were given epidural anesthesia and assessed for heart rate and mean arterial pressure
| Study group | Role | What they receive |
|---|---|---|
| group receiving thoracic epidural anesthesia | Active comparator | Not described Receives: Drug: Thoracic epidural effect on heart rate in Laparoscopic Cholecystectomy (bupivacaine and lignocaine) |
| group receiving thoracic general anesthesia | Active comparator | Not described Receives: Drug: general anesthesia effect on heart rate in Laparoscopic Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of thoracic epidural anesthesia with general anesthesia for Laparoscopic cholecystectomy in terms of change in heart rate during surgery in immediate 24 hours-heart rate.
the efficacy of thoracic epidural anesthesia was compared with general anesthesia for laproscopic cholecystectomy in the immediate post operative period in terms of intra operative heart rate.
Measured: changes in heart rate at 24 hours of surgery.
effectiveness of thoracic epidural anesthesia with general anesthesia for Laparoscopic cholecystectomy in terms of change in mean arterial blood pressure during surgery in immediate 24 hours-mean arterial blood pressure.
efficacy of thoracic epidural anesthesia was compared with general anesthesia for laproscopic cholecystectomy in the immediate post operative period in terms of mean arterial blood pressure intra operatively and in immediate post operative period
Measured: changes in mean arterial pressure at 24 hours of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Oct 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural AnesthesiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one group to be studied for effects of epidural anesthesia and other group for effects of general anesthesia
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, arshad khushdil, Armed Forces Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721054
- Sponsor's protocol ID
- 104589
- Status last verified
- Jan 2021
- First submitted
- 2 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Epidural Versus General Anesthesia for Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04721054
- Acronym / sponsor ID
- 104589
- Conditions
- Epidural Anesthesia, General Anesthesia
- Keywords
- headache, blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Armed Forces Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 22 Jan 2021 (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.
Eighty two patients planned to undergo elective laparoscopic cholecystectomy were divided into two groups, T and G, randomly. In Group T all patients underwent laparoscopic cholecystectomy under thoracic epidural anesthesia with 12mlof 0.25% bupivacaine and 1% lignocaine plain whereas in group G all patients underwent surgery under general anesthesia. Intra-operative heart rate, mean arterial pressure (MAP) and post operative opioid consumption in first 24hrs were recorded as primary outcomes whereas presence or absence of respiratory complication and duration of hospital stay as secondary outcome.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- one group to be studied for effects of epidural anesthesia and other group for effects of general anesthesia
| Arm | Type | Receives |
|---|---|---|
| group receiving thoracic epidural anesthesia | Active comparator | Drug: Thoracic epidural effect on heart rate in Laparoscopic Cholecystectomy (bupivacaine and lignocaine) |
| group receiving thoracic general anesthesia | Active comparator | Drug: general anesthesia effect on heart rate in Laparoscopic Cholecystectomy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients having ASA statusI-III
- age more than 18 years,
- both genders
- planned to undergo laparoscopic cholecystectomy
Key exclusion criteria (4 listed)
- Patients who did not give consent,
- Allergic to local anesthetic
- Hemodynamically unstable,
- Pregnant, full stomach patients
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 |
|---|---|---|
| Thoracic epidural effect on heart rate in Laparoscopic Cholecystectomy (bupivacaine and lignocaine)Also: Thoracic epidural effect on mean arterial pressure in Laparoscopic Cholecystectomypatients in epidural anesthesia were given epidural anesthesia and assessed for heart rate and mean arterial pressure | Drug | group receiving thoracic epidural anesthesia |
| general anesthesia effect on heart rate in Laparoscopic CholecystectomyAlso: general anesthesia effect on mean arterial pressure in Laparoscopic Cholecystectomypatients in general anesthesia were given epidural anesthesia and assessed for heart rate and mean arterial pressure | Drug | group receiving thoracic general anesthesia |
Primary outcome
effectiveness of thoracic epidural anesthesia with general anesthesia for Laparoscopic cholecystectomy in terms of change in heart rate during surgery in immediate 24 hours-heart rate.
Time frame: changes in heart rate at 24 hours of surgery.
the efficacy of thoracic epidural anesthesia was compared with general anesthesia for laproscopic cholecystectomy in the immediate post operative period in terms of intra operative heart rate.
effectiveness of thoracic epidural anesthesia with general anesthesia for Laparoscopic cholecystectomy in terms of change in mean arterial blood pressure during surgery in immediate 24 hours-mean arterial blood pressure.
Time frame: changes in mean arterial pressure at 24 hours of surgery
efficacy of thoracic epidural anesthesia was compared with general anesthesia for laproscopic cholecystectomy in the immediate post operative period in terms of mean arterial blood pressure intra operatively and in immediate post operative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic epidural effect on heart rate in Laparoscopic Cholecystectomy (bupivacaine and lignocaine) and general anesthesia effect on heart rate in Laparoscopic Cholecystectomy in people with Epidural Anesthesia and General Anesthesia, run by Armed Forces Hospital, Pakistan at 1 site in Pakistan.
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 4 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: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of thoracic epidural anesthesia with general anesthesia for Laparoscopic cholecystectomy in terms of change in heart rate during surgery in immediate 24 hours-heart rate. (time frame: changes in heart rate at 24 hours of surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2021; AzTrials last refreshed its copy on 31 Oct 2026.