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Dexmedetomidine Versus Magnesium Sulfate as Adjuvants to Intraperitoneal Bupivacaine for Postoperative Analgesia After Elective Laparoscopic Cholecystectomy

Efficacy of Dexmedetomidine Versus Magnesium Sulfate as Adjuvants to Intraperitoneal Bupivacaine for Postoperative Analgesia in Patients Undergoing Elective Laparoscopic Cholecystectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06879288
Enrollment
75
Registered
2025-03-17
Start date
2023-07-01
Completion date
2025-02-01
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjuvants, Dexmedetomidine, Elective Laparoscopic Cholecystectomy, Intraperitoneal Bupivacaine, Magnesium Sulfate, Postoperative Analgesia

Brief 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.

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.

Interventions

DRUGMagnesium sulfate

Patients received intraperitoneal bupivacaine plus magnesium sulfate at the end of the operations.

DRUGBupivacaine

Patients received intraperitoneal bupivacaine only at the end of the operations.

DRUGDexmedetomidine

Patients received intraperitoneal bupivacaine plus dexmedetomidine at the end of the operations.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Age from 21 to 65 years. * Both sexes. * American Society of Anesthesiologists (ASA) class I-III. * Scheduled to undergo elective laparoscopic cholecystectomy.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Degree of pain24 hours postoperativelyDegree 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.

Secondary

MeasureTime frameDescription
Time to the first rescue analgesia request24 hours postoperativelyTime to the first rescue analgesia request (time from the end of surgery till first dose of morphine administrated)
Total morphine consumption24 hours postoperativelyIf Numerical rating score (NRS)-S \>4, IV 3 mg morphine was given as a rescue analgesia.
Level of sedation24 hours postoperativelyLevel of sedation using Ramsey scale at 1, 2, 4, 8, 16, and 24 hours postoperative from 1 to 6: 1. Patient is anxious and agitated. 2. Patient is co-operative and oriented. 3. Patient responds to commands only. 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus. 5. Patient exhibits sluggish response to light glabellar tap or loud auditory stimulus. 6. Patient exhibits no response.
Lenght of hospital stay1 week postoperativelyLength of hospital stay was recorded from admission till discharge from hospital.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026