Preoperative Gabapentin Versus Bisoprolol for Hemodynamic Optimization During Sinus Surgery

Blood Pressure Clinical Trial

Official title:

Preoperative Gabapentin Versus Bisoprolol for Intraoperative Hemodynamic and Surgical Field Optimization During Endoscopic Sinus Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03850093
• Other study ID #: ZU-IRB 2139-24-5-2015
• Status: Completed
• Phase: Phase 4
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: February 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the current study hypothesized that Gabapentin can be effective as Bisoprolol in reduction of intraoperative bleeding, improving the operative's field visibility and increase the surgeon satisfaction via optimization of blood pressure and heart rate .

A prospective randomized double blinded controlled study. Eligible patients were randomized according to random list generated software and allocated into 3 equal and matched groups (15 patients in each group):-

• Group G: gabapentin group in which Patients were premedicated with oral gabapentin 1200 mg (Conventin 400mg; Evapharm) with sips of water, 2 hours before induction of anesthesia.

• Group B: bisoprolol group in which Patients were premedicated with oral bisoprolol 2.5 mg ( Concor 2.5mg ; Merck/Amoun ) with sips of water, 2 hours before induction of anesthesia.

• Group C: control group in which Patients were premedicated with oral placebo with sips of water, 2 hours before induction of anesthesia.

Description:

Hypothesis:

Gabapentin can be effective as Bisoprolol in reduction of intraoperative bleeding, improving the operative's field visibility and increase the surgeon satisfaction via optimization of blood pressure and heart rate.

Objectives Compare the effect of preoperative Gabapentin with Bisoprolol on hemodynamics, surgical field optimization during endoscopic nasal surgeries.

Technical design:

A) Site of study :

The study was conducted at Anesthesia and Surgical intensive care and Otorhinolaryngology departments, faculty of medicine, Zagazig University.

B) Sample Size :

According to 80% power of the study, 95% CI and calculated volume of blood loss 200±40 ml and 150±55ml on Gabapentin (22) and Bisoprolol (15) premedication respectively, the estimated Sample size was 54 patients (open EPI) , 63 patients were included in the study to compensate for drop out.

Randomization was carried out on 63 patients to compensate for drop out . All planned ESS procedures was managed by the same anesthetist and surgeon who were blinded to the used study's premedication. The surgeon was blinded to the monitor recording the hemodynamic variables.

All patients had been preoperatively evaluated according to standard local protocol. Preoperative surgical preparation and proper management of infection were confirmed to every patient.

Patient was premedicated by IV ranitidine 50 mg, midazolam 0.05 mg/kg and atropine 20µg/kg immediately before admission to the operating room.

On admission to the operating room, Standard monitoring included 5 leads ECG, non-invasive blood pressure, Pulse Oximetry and End-tidal carbon dioxide (ETCO2) trace were applied (B40i Monitor - GE Healthcare, Finland).

Anesthesia was induced with IV propofol 2 mg/kg and fentanyl 1 µg/kg was given for analgesia. Cisatracurium 0.15 mg/kg IV was given to facilitate direct laryngoscopy and orotracheal intubation. The patient was ventilated at tidal volume 6-8mL/kg and respiratory rate that achieved ETCO2 of 30-35 mmHg. Oropharyngeal pack was inserted.

Anesthesia was maintained by isoflurane based on MAC 1.2 % until a steady state of anesthesia was achieved (defined as a state of anesthesia when no changes in hemodynamic variables take place for at least 10 min). An increase of ≥ 20% of basal value in both HR and MAP was treated with increasing the concentration of isoflurane by 0.5% and increments of fentanyl 1 μg/kg. Muscle relaxation was confirmed by cisatracurium 0.03mg/kg every 20 mins. IV lactated ringer solution was infused at approximately 6ml/kg/hr till the end of the procedure.

All patients were positioned supine and the bed-head of the surgical table was raised by 30° to improve venous drainage.

Before the beginning of surgical procedure, well wrung out cotton pledgets soaked with 4 ml of 2% lignocaine with 1:200,000 adrenaline were topically applied to the nasal mucous membrane for 10 min (no infiltration).

Technique for hemodynamic optimization:

Target mean arterial pressure (MAP) was 60-70 mmHg during the surgical procedure to achieve Fromm and Boezaart category scale of 2 or 3 which is judged to be optimal for surgery (20).

If the MAP was still ˃70mmHg in spite of increasing isoflurane inhalation to 2.5%, nitroglycerine (1-10 μg/kg/min.) titrated to effect.

If the heart rate was more than 100 beats/ minute, propranolol was titrated 1-3 mg/hour to achieve target MAP.

If mean arterial pressure (MAP) decreased to less than 60 mm Hg, ephedrine in increments of 3 mg was given.

Withdrawal vasoactive agents:

After recording the surgeons' opinion regarding the surgical field and about 15 minutes before ending surgery, the infusion of any vasoactive medication (if used) was stopped and the anesthetic agent was decreased allowing HR and MAP to return to their basal value. If Hypotension (defined as SAP< 90mmHg and bradycardia less than 60 bpm) persisted, they was treated by ephedrine in increments of 3 mg .

On compilation of surgical procedure, anesthesia was discontinued and reversal of neuromuscular blockade was achieved using IV neostigmine 0.08 mg/kg and atropine 20µg/kg. After removal of oropharyngeal pack, oropharyngeal suction was performed. On the start of obeying commands, patients were extubated and shifted to recovery room.

Patients were discharged to the ward after reaching a score ≥ 9 on the Modified Aldrete Scoring System.

During postoperative period up to 6 hours, the patient was monitored for conscious level, oxygen saturation, heart rate and mean arterial blood pressure.

On ward admission, IM diclofenac sodium 75mg was given then every 12 hours. If the patient complained moderate to severe pain (VAS≥ 4) meperidine 25mg increments up to pain relief (maximum 100mg as a single dose) was given.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• patients who underwent functional endoscopic sinus surgery

• ability to swallow tablets

Exclusion Criteria:

• suspected difficult airway

• basal HR <60/min.

• chronic cardiovascular or cerebrovascular disease

• bronchial asthma or COPD

• DM

• bleeding disorders

• anemia (Hb level< 10 gm/dl)

• renal or hepatic insufficiency

• psychiatric disorders

• chronic treatment by BBs, gabapentin or drugs that affect coagulation

• acute nasal infection

• allergy/contraindications to any of the study's drugs.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Drug:
• Gabapentin1200 mg
patients received 1200mg gabapentin 2 hrs preoperative
• bisoprolol 2.5mg
patients received 2.5mg bisoprolol 2 hrs preoperative
• placebo
patients received oral placebo 2 hrs preoperative

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surgeon Satisfaction (Categorical)	surgeon satisfaction score where given 5 for very satisfied, 4 for satisfied, 3 for neutral, 2 for dissatisfied and 1 for very dissatisfied then number of satisfied (satisfaction score = 5) and disatisfied (satisfaction score less than 5) surgeons was compared between groups	at the end of surgery
Other	Number of Patients Who Recieved Intraoperative IV Nitroglycerin During Operative Procedure	need for additional intraoperative IV vasodilators (nitroglycerine	at the end of surgery
Other	Number of Patients Who Recieved Intraoperative IV Propranolol During Operative Procedure	the need for additional beta blockers (propranolol)	at the end of surgery
Other	Number of Patients Who Recieve Both IV Nitroglycerin and Propranolol During Operative Procedure	need for both IV nitroglycerine and propranolol intraoperatively	at the end of surgery
Other	Visual Analogue Scale (VAS) for Postoperative Pain	postoperative visual analogue score (VAS) for pain where 0 is no pain and 10 severe intolerable pain which was assessed	1, 3 and 6 hrs. after recovery
Other	Visual Analogue Scale (VAS) for Postoperative Pain	postoperative visual analogue score (VAS) for pain where 0 is no pain and 10 severe intolerable pain	0n full recovery, 3 and 6 hrs. after recovery
Other	Time to 1st Postoperative Rescue Analgesia	time to 1st postoperative rescue analgesia (starting from administration of the studied drug)	on administration of 1st postoperative rescue analgesia
Primary	Changes in Surgical Field Visibility	according to change in Fromm and Boezaart surgical field category scale ranging from 0 (no bleeding) to 5 (severe bleeding) where: 0 No Bleeding.; Slight bleeding- no blood suctioning required.; Slight bleeding- occasional blood suctioning required.; Slight bleeding- frequent blood suctioning required, operative field is visible for some seconds after evacuation.; Moderate bleeding- frequent blood suctioning required, operative field is only visible immediately after evacuation.; Severe bleeding- constant blood suctioning required, bleeding appears faster than can be removed by suction .Surgery is hardly possible, and sometimes impossible.	scale was assessed by the surgeon every 15 minutes from the start of surgical procedure till the end
Primary	Blood Loss	total intraoperative blood loss (mL)	at the end of surgery
Secondary	Heart Rate Change	effect of intervention on the change of heart rate allover study period	were recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgery
Secondary	Mean Arterial Blood Pressure Change	effect of intervention on the change of mean arterial blood pressure allover study period	were recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgery