Evaluation of the Analgesic Effect of Dexmedetomidine Versus Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine Surgeries

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 4, 2018

Primary Completion Date

May 2, 2018

Study Completion Date

May 6, 2018

Conditions
Dexmedetomidine VS Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine Surgeries
Interventions
DRUG

Dexmedetomidine

"All cases of spine surgery will be done under G.A with the patient in prone position. After surgery an epidural catheter will be placed through a separate skin puncture above the incision The catheter will be positioned up to 7 cm from skin entry directing downwards in the epidural space . Once the patient in the post-operative room will be noted to have pain (VAS) of\>4, the study will start. A test dose of 3 ml lignocaine with adrenaline will be injected the following parameters will be noted .~1. The pain score, by using VAS~2. Onset of analgesia (fall of VAS\<4 ).~3. Peak level of analgesia ( VAS score 0).~4. Duration of analgesia (once the patient asks fwith VAS\>4).~5. Monitoring of NIBP, pulse rate, respiratory rate every 30 min.~6. Side-effects such as nausea, vomiting, respiratory depression, Motor blockade Bromage scale\>1 Also deep sedation Ramsay sedation scale\>3 , And shivering and hypotension."

DRUG

Bupivacaine

"All cases of spine surgery will be done under G.A with the patient in prone position. After surgury an epidural catheter will be placed through a separate skin puncture above the incision The catheter will be positioned up to 7 cm from skin entry directing downwards in the epidural space . Once the patient in the post-operative room will be noted to have pain (VAS) of\>4, the study will start. A test dose of 3 ml lignocaine with adrenaline will be injected the following parameters will be noted .~1. The pain score, by using VAS~2. Onset of analgesia (fall of VAS\<4 ).~3. Peak level of analgesia ( VAS score 0).~4. Duration of analgesia (once the patient asks fwith VAS\>4).~5. Monitoring of NIBP, pulse rate, respiratory rate every 30 min.~6. Side-effects such as nausea, vomiting, respiratory depression, Motor blockade Bromage scale\>1 Also deep sedation Ramsay sedation scale\>3 , And shivering and hypotension."

DRUG

Fentanyl

"All cases of spine surgery will be done under G.A with the patient in prone position. After surgury an epidural catheter will be placed through a separate skin puncture above the incision The catheter will be positioned up to 7 cm from skin entry directing downwards in the epidural space . Once the patient in the post-operative room will be noted to have pain (VAS) of\>4, the study will start. A test dose of 3 ml lignocaine with adrenaline will be injected the following parameters will be noted .~1. The pain score, by using VAS~2. Onset of analgesia (fall of VAS\<4 ).~3. Peak level of analgesia ( VAS score 0).~4. Duration of analgesia (once the patient asks fwith VAS\>4).~5. Monitoring of NIBP, pulse rate, respiratory rate every 30 min.~6. Side-effects such as nausea, vomiting, respiratory depression, Motor blockade Bromage scale\>1 Also deep sedation Ramsay sedation scale\>3 , And shivering and hypotension."

Trial Locations (1)

11451

Ahmed Abdalla Mohamed, Cairo

All Listed Sponsors
collaborator

Mohamed, Ahmed A., M.D.

INDIV

collaborator

Tarek Ahmed Radwan

UNKNOWN

collaborator

Mohamed Mahmoud Mohamed

UNKNOWN

collaborator

ismaiel saied hammad

UNKNOWN

lead

Cairo University

OTHER

NCT03463083 - Evaluation of the Analgesic Effect of Dexmedetomidine Versus Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine Surgeries | Biotech Hunter | Biotech Hunter