Dexmedetomidine Versus Fentanyl Plus Bupivacaine for Epidural Analgesia With General Anesthesia for Lumbar Disc Operations

Anesthesia Clinical Trial

Official title:

Adding Dexmedetomidine Versus Fentanyl to Bupivacaine for Epidural Analgesia in Combination With General Anesthesia for Elective Lumbar Disc Operations: Prospective, Randomized Double-blinded Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438240
• Other study ID #: FMASU R8 /2018
• Status: Completed
• Phase: Phase 4
• Start date: February 12, 2018
• Est. completion date: August 15, 2018

Study information

• Verified date: February 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare addition of dexmedetomidine or fentanyl to bupivacaine for epidural analgesia in combination with general anesthesia in elective lumbar spine operations as regard hemodynamic stability, postoperative pain control and adverse effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 15, 2018
• Est. primary completion date: July 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Physical status American Society of Anesthesiologist (ASA) I or II.

• First time elective lumbar dicsectomy or laminectomy

Exclusion Criteria:

• Patients who refuse to participate

• Body mass index (BMI) > 30

• Need an emergency lumbar disc operation

• ASA physical status > II

• Major illnesses (e.g. cardiac, respiratory, renal, liver)

• Coagulation abnormalities

• Hypovolemia

• History of increased intracranial pressure

• Convulsions

• Spinal stenosis

• Infection at needle insertion site

• Other contraindications to epidural procedure

• Allergy or contraindications to the drugs used in the study

• History of addiction or alcohol abuse

• Psychiatric illness or mental retardation

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Bupivacaine
patients will receive combined general anesthesia / epidural analgesia with 15 ml bupivacaine 0.20%
• Fentanyl
Plus 50 µg fentanyl
• Dexmedetomidine
Plus 50 µg dexmedetomidine

Locations

Country	Name	City	State
Egypt	Ain Shams University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First time to analgesic requirement	After extubation, an intravenous patient-controlled analgesia system, will be connected to the patient (Accufuser Plus® 100 ml, Woo Young Medical Co, Korea) will be prepared with 60 ml normal saline containing 60 mg morphine, it will be programmed to give and 0.5 ml bolus dose with lockout interval of 8 minutes. Time to first Bolus will be estimated considering extubation time is the zero time.	First 24 hours postoperatively
Secondary	Total opioid consumption	Total morphine consumption per twenty four hours will be estimated	First 24 hours postoperatively
Secondary	Visual analogue scale (VAS)	Pain scores will be evaluated by a blinded observer anesthesiologist at the time of arrival in the PACU, and 10, 20, 30 minutes, 1 h, 2h, 4, 6, 8, 10, 12, 16 and 24 hr thereafter using visual analogue scale (VAS) (0-10 cm: 0 = no pain, 10 = the worst pain possible). The patients will be instructed about usage of VAS preoperatively	First 24 hours postoperatively