DexmedetomidineNCT06879288
Dexmedetomidine Versus Magnesium Sulfate as Adjuvants to Intraperitoneal Bupivacaine for Postoperative Analgesia After Elective Laparoscopic Cholecystectomy
A study testing Bupivacaine, Dexmedetomidine and Magnesium sulfate in people with Dexmedetomidine and Magnesium Sulfate, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to assess the efficiency of dexmedetomidine against magnesium sulfate as adjuvants to intraperitoneal bupivacaine for postoperative analgesia in individuals having elective laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Dexmedetomidine, Magnesium Sulfate, Adjuvants
- What is being tested?
- Bupivacaine, Dexmedetomidine and Magnesium sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Feb 2025
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 21 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) class I-III.
- Scheduled to undergo elective laparoscopic cholecystectomy.
Who cannot join
- Patient refusal.
- Body mass index ≥40.
- Allergy to the study drugs.
- Advanced cardiac, renal and hepatic diseases.
- Patients with peritoneal drain or peritoneal wash after surgery.
- Uncooperative patients.
- Chronic pain medications.
- Hypomagnesaemia or hypermagnesaemia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Dexmedetomidine Versus Magnesium Sulfate as Adjuvants to Intraperitoneal Bupivacaine for Postoperative Analgesia in Patients Undergoing Elective Laparoscopic Cholecystectomy
This study aimed to assess the efficiency of dexmedetomidine against magnesium sulfate as adjuvants to intraperitoneal bupivacaine for postoperative analgesia in individuals having elective laparoscopic cholecystectomy.
Read the detailed description
Pain after laparoscopy is less intense than after laparotomy, but laparoscopy is not pain free and analgesia after this type of surgery is inadequately studied. Intraperitoneal (IP) instillation/nebulization of local anesthetics has been used as a method for reducing postoperative pain and opioid use following laparoscopy through acting on visceral nociceptors of the peritoneum.
Bupivacaine is indicated for local infiltration, peripheral nerve block, sympathetic nerve block, and epidural and caudal blocks. It is available mixed with a small amount of epinephrine to increase the duration of its action. It typically begins working within 15 minutes and lasts for 2 to 8 hours.
Dexmedetomidine is a selective alpha-2 (α2) adrenergic agonist known to have analgesic and sedative characteristics that can augment the duration of action of local anesthetics.
Magnesium is an N-methyl-D-aspartate receptor antagonist in addition to its effects on calcium influx. The anti-inflammatory and opioid-sparing effects make it a popular component of opioid free anaesthesia. It is extensively used for perioperative analgesia in a dose of 30- to 50-mg/kg intravascular bolus followed by a 10- to 15-mg/kg/h infusion.
- Conditions
- Dexmedetomidine, Magnesium Sulfate, Adjuvants, Intraperitoneal Bupivacaine, Postoperative Analgesia, Elective Laparoscopic Cholecystectomy
- Being tested
- Bupivacaine, Dexmedetomidine, Magnesium sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Patients received intraperitoneal bupivacaine only at the end of the operations.
DexmedetomidineDrug
Patients received intraperitoneal bupivacaine plus dexmedetomidine at the end of the operations.
Magnesium sulfateDrug
Patients received intraperitoneal bupivacaine plus magnesium sulfate at the end of the operations.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine group | Active comparator | Patients received intraperitoneal bupivacaine only at the end of the operations. Receives: Drug: Bupivacaine |
| Dexmedetomidine group | Experimental | Patients received intraperitoneal bupivacaine plus dexmedetomidine at the end of the operations. Receives: Drug: Dexmedetomidine |
| Magnesium group | Experimental | Patients received intraperitoneal bupivacaine plus magnesium sulfate at the end of the operations. Receives: Drug: Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
Degree of pain was assessed using the numerical rating score (NRS) (from 0 = no pain, to 10 = the most severe pain).NRS was assessed at 1, 2, 4, 8, 16, and 24 hours postoperative.
Measured: 24 hours postoperatively
Secondary outcomes (4)
Time to the first rescue analgesia request
Time to the first rescue analgesia request (time from the end of surgery till first dose of morphine administrated)
Measured: 24 hours postoperatively
Total morphine consumption
If Numerical rating score (NRS)-S >4, IV 3 mg morphine was given as a rescue analgesia.
Measured: 24 hours postoperatively
Level of sedation
Level of sedation using Ramsey scale at 1, 2, 4, 8, 16, and 24 hours postoperative from 1 to 6:
- Patient is anxious and agitated.
- Patient is co-operative and oriented.
- Patient responds to commands only.
- Patient exhibits brisk response to light glabellar tap or loud auditory stimulus.
- Patient exhibits sluggish response to light glabellar tap or loud auditory stimulus.
- Patient exhibits no response.
Measured: 24 hours postoperatively
Lenght of hospital stay
Length of hospital stay was recorded from admission till discharge from hospital.
Measured: 1 week postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Jul 2023
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Mahmoud Rabee El Gazzar, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879288
- Sponsor's protocol ID
- 36264MS215/6/23
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dexmedetomidine Versus Magnesium Sulfate as Adjuvants to Intraperitoneal Bupivacaine for Postoperative Analgesia in Patients Undergoing Elective Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06879288
- Acronym / sponsor ID
- 36264MS215/6/23
- Conditions
- Dexmedetomidine, Magnesium Sulfate, Adjuvants, Intraperitoneal Bupivacaine, Postoperative Analgesia, Elective Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 17 Mar 2025 (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.
This study aimed to assess the efficiency of dexmedetomidine against magnesium sulfate as adjuvants to intraperitoneal bupivacaine for postoperative analgesia in individuals having elective laparoscopic cholecystectomy.
Detailed description
Pain after laparoscopy is less intense than after laparotomy, but laparoscopy is not pain free and analgesia after this type of surgery is inadequately studied. Intraperitoneal (IP) instillation/nebulization of local anesthetics has been used as a method for reducing postoperative pain and opioid use following laparoscopy through acting on visceral nociceptors of the peritoneum.
Bupivacaine is indicated for local infiltration, peripheral nerve block, sympathetic nerve block, and epidural and caudal blocks. It is available mixed with a small amount of epinephrine to increase the duration of its action. It typically begins working within 15 minutes and lasts for 2 to 8 hours.
Dexmedetomidine is a selective alpha-2 (α2) adrenergic agonist known to have analgesic and sedative characteristics that can augment the duration of action of local anesthetics.
Magnesium is an N-methyl-D-aspartate receptor antagonist in addition to its effects on calcium influx. The anti-inflammatory and opioid-sparing effects make it a popular component of opioid free anaesthesia. It is extensively used for perioperative analgesia in a dose of 30- to 50-mg/kg intravascular bolus followed by a 10- to 15-mg/kg/h infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine group | Active comparator | Drug: BupivacainePatients received intraperitoneal bupivacaine only at the end of the operations. |
| Dexmedetomidine group | Experimental | Drug: DexmedetomidinePatients received intraperitoneal bupivacaine plus dexmedetomidine at the end of the operations. |
| Magnesium group | Experimental | Drug: Magnesium sulfatePatients received intraperitoneal bupivacaine plus magnesium sulfate at the end of the operations. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 21 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) class I-III.
- Scheduled to undergo elective laparoscopic cholecystectomy.
Key exclusion criteria (8 listed)
- Patient refusal.
- Body mass index ≥40.
- Allergy to the study drugs.
- Advanced cardiac, renal and hepatic diseases.
- Patients with peritoneal drain or peritoneal wash after surgery.
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 |
|---|---|---|
| BupivacainePatients received intraperitoneal bupivacaine only at the end of the operations. | Drug | Bupivacaine group |
| DexmedetomidinePatients received intraperitoneal bupivacaine plus dexmedetomidine at the end of the operations. | Drug | Dexmedetomidine group |
| Magnesium sulfatePatients received intraperitoneal bupivacaine plus magnesium sulfate at the end of the operations. | Drug | Magnesium group |
Primary outcome
Degree of pain
Time frame: 24 hours postoperatively
Degree of pain was assessed using the numerical rating score (NRS) (from 0 = no pain, to 10 = the most severe pain).NRS was assessed at 1, 2, 4, 8, 16, and 24 hours postoperative.
4 secondary outcomes
Time to the first rescue analgesia request
Time frame: 24 hours postoperatively
Total morphine consumption
Time frame: 24 hours postoperatively
Level of sedation
Time frame: 24 hours postoperatively
Lenght of hospital stay
Time frame: 1 week postoperatively
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 17 Mar 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Bupivacaine, Dexmedetomidine and Magnesium sulfate in people with Dexmedetomidine and Magnesium Sulfate, run by Tanta University at 1 site in Egypt.
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 8 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 17 Mar 2025. 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 Egypt. 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?
Degree of pain (time frame: 24 hours postoperatively). 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 17 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.